The 3 Ball Breath Exerciser is a professional respiratory training device designed to enhance respiratory muscle strength, improve lung capacity, and optimize pulmonary ventilation function. It adopts a multi-level resistance design with three floating balls, allowing users to perform progressive inspiratory or expiratory training by adjusting airflow intensity. Suitable for post-operative lung rehabilitation, chronic respiratory disease management, athletic performance enhancement, and daily respiratory health maintenance, this device serves as a critical tool in hospitals, rehabilitation centers, fitness facilities, and home care settings.
Crafted from medical-grade, non-toxic, and durable materials, the exerciser features a transparent cylindrical chamber that enables real-time visual feedback of ball elevation, helping users monitor training intensity intuitively. The three color-coded floating balls correspond to different resistance levels, catering to diverse training needs from beginners to advanced users. The ergonomic mouthpiece is designed for comfortable, leak-proof contact with the lips, while the detachable structure facilitates easy cleaning and disinfection. No external power supply or complex assembly is required-users can start training immediately by inhaling or exhaling through the mouthpiece. Each unit complies with ISO 13485, CE, and NMPA medical device standards, undergoing strict quality testing to ensure resistance accuracy, structural stability, and biocompatibility.
Product Specification
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Item |
Description |
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Application |
Enhances respiratory muscle strength; improves lung capacity and ventilation efficiency; aids post-operative lung rehabilitation; manages chronic respiratory diseases; optimizes athletic performance |
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Core Components |
Transparent cylindrical chamber, three color-coded floating balls, ergonomic mouthpiece, adjustable resistance valve, detachable base, air inlet/outlet vents |
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Material |
Medical-grade ABS (cylinder body); food-grade silicone (mouthpiece); PP (floating balls); stainless steel (internal springs) |
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Compatible Populations |
Adults, adolescents, pediatric patients (≥6 years old); suitable for post-operative patients, COPD sufferers, asthma patients, athletes, and individuals with weakened respiratory function |
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Key Safety Features |
Non-toxic biocompatible materials, leak-proof mouthpiece design, durable structure resistant to deformation, detachable for thorough disinfection |
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Dimensions |
18×6×6 cm (length×diameter) |
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Sterility |
EO-sterilized (single-use); Reusable (supports high-temperature disinfection) |
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Shelf Life |
3 years (single-use, unopened and properly stored); 5 years (reusable, excluding wear from repeated disinfection) |
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Accessory |
Waterproof storage case, cleaning brush, user manual with training guidelines, resistance level chart |
Product Properties
- Progressive Resistance Training: Three color-coded floating balls (red, yellow, blue) correspond to low, medium, and high resistance levels (5-15 cmH₂O), enabling step-by-step training to gradually strengthen diaphragmatic and intercostal muscles.
- Intuitive Visual Feedback: Transparent chamber allows users to track ball elevation during inhalation/exhalation, helping maintain consistent training intensity and motivating progress monitoring.
- Dual-Mode Training: Supports both inspiratory and expiratory training (switchable via internal valve), comprehensively improving respiratory muscle endurance and pulmonary ventilation efficiency.
- Ergonomic & User-Friendly Design: Soft silicone mouthpiece reduces lip irritation; lightweight (≤100g) and compact size facilitate portability for on-the-go training; detachable parts allow easy cleaning to prevent bacterial growth.
- Universal Adaptability: Adjustable resistance valve accommodates individual fitness levels and recovery needs; compatible with oxygen therapy devices for combined respiratory support and training; suitable for long-term daily use without side effects.
Application Scenarios
- Post-Operative Rehabilitation: Hospitals and rehabilitation centers for patients recovering from thoracic, abdominal, or orthopedic surgeries to prevent atelectasis and promote lung expansion.
- Chronic Respiratory Disease Management: Home care and clinics for patients with COPD, asthma, or interstitial lung disease to alleviate symptoms, reduce exacerbations, and improve quality of life.
- Athletic Training: Fitness centers, sports teams, and individual athletes (runners, swimmers, cyclists) to enhance respiratory muscle endurance and oxygen uptake, boosting athletic performance.
- Geriatric Health Care: Nursing homes and community health centers for elderly individuals to prevent age-related decline in lung function and reduce the risk of respiratory infections.
- Occupational Health: Workplaces with high physical demands (e.g., construction, mining) or low-oxygen environments (e.g., high-altitude work) to strengthen respiratory capacity and protect lung health.
- Pediatric Respiratory Training: Pediatric clinics and homes for children (≥6 years old) with recurrent respiratory infections or mild asthma to improve respiratory fitness in a fun, engaging way.
Physical Properties
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Item |
Specification |
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Operating Temperature |
-5℃~50℃ |
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Material Hardness |
Chamber body: Shore D 70-80; Silicone mouthpiece: Shore A 35-45 |
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Product Weight |
80-100g (empty) |
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Chamber Volume |
250-300ml |
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Resistance Levels |
Low (Red): 5-8 cmH₂O; Medium (Yellow): 9-12 cmH₂O; High (Blue): 13-15 cmH₂O |
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Airflow Rate Range |
10-60 L/min |
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Mouthpiece Diameter |
Adult: 2.5-3 cm; Pediatric: 1.8-2.2 cm |
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Leakage Rate |
≤5% (at maximum resistance) |
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Durability |
Withstands ≥10,000 cycles of training without structural damage |
QA&QC
Certifications: Fully complies with ISO 13485 medical device quality management system standards, CE medical device certification, and NMPA registration requirements. Each production batch undergoes rigorous quality testing:
Resistance Accuracy Test: Verifies that each resistance level meets specified pressure ranges under simulated respiratory flow rates.
Leakage Test: Ensures no air leakage from the chamber, mouthpiece, or valve connections during training.
Biocompatibility Assessment: Conducts cytotoxicity, skin sensitization, and oral mucosal irritation tests on all contact materials.
Durability Test: Simulates long-term use to confirm structural stability and resistance to deformation or breakage.
Visual Feedback Test: Validates that floating balls respond consistently to airflow without jamming or sticking.
Each product is marked with a unique batch number for full traceability of production, inspection, and distribution. A detailed Instruction for Use (IFU) is provided, including training protocols, resistance level selection guidelines, cleaning methods, and safety precautions.
Packing, Storage, Handling and Transportation
Packing:
Single-use versions: Individually packaged in EO-sterilized paper-plastic composite bags, with a waterproof storage case, cleaning brush, and user manual included. Each package is printed with product information, sterilization date, batch number, and expiration date.
Reusable versions: Packaged in PE bags with disinfection guidelines and accessory kits (cleaning brush, resistance chart). Bulk transport in sturdy corrugated cartons with anti-collision foam inserts to prevent structural damage.
Storage:
Store in a clean, dry, well-ventilated environment with a temperature of -5℃~50℃ and relative humidity ≤80%.
Avoid direct sunlight, high temperature, high humidity, and contact with sharp objects or corrosive substances (e.g., acids, alkalis).
Keep single-use products sealed until use; do not open the package in non-sterile environments.
Stack cartons no more than 12 layers to prevent crushing the products inside.
Handling:
Single-use products: Discard immediately after use to avoid cross-infection; do not reuse or disinfect.
Reusable products: After each use, disassemble the mouthpiece and chamber, clean with warm water and neutral detergent, then disinfect by boiling (100℃, 10 minutes) or autoclave (121℃, 15 minutes). Inspect for cracks, mouthpiece damage, or resistance valve blockage before reuse; discard if any defects are found.
Avoid dropping or impact during handling; do not use if the transparent chamber is cloudy, brittle, or leaking.
Transportation:
Transport in accordance with national and international medical device transportation regulations, avoiding violent collision, jolting, rain, or moisture.
Use shockproof packaging for long-distance transportation; avoid mixing with heavy or sharp items that may cause damage.
The transportation process shall be recorded, including departure date, destination, transportation conditions, and receiver information, for full traceability.
Reasons for choosing us
Zhejiang Mediunion Healthcare Group Co. Ltd. (a branch of Evergrand Healthcare Group, founded in 2014) is located in Ningbo City, Zhejiang Province - enjoying an excellent location and convenient transportation. Our business covers medical device manufacturing & sales, plus investments in nursing homes, dental clinics, specialist hospitals and medical care services. Our products are sold worldwide, and we've won global consumer recognition with high-quality goods and comprehensive after-sales service.
Diversified Product Portfolio
Our product range includes disposable medical consumables, medical equipment and non-woven products (e.g. dental supplies, respiratory care items). This diverse lineup caters to the needs of medical institutions, clinics and other clients.
Reliable Supply & Collaboration
We have rich industry experience and partner with over 600 factories. These partners are equipped with advanced production equipment and skilled frontline staff, enabling us to produce customized products/components as per specific requests.
Strict Quality Assurance
We prioritize innovation & quality, backed by the ISO 13485:2016 quality management system. Strict control runs through raw material procurement, mass production, process management and finished product release. Our professional services (production control, order follow-up, delivery) also set us apart.
Certificate
FAQ
Q:Can you provide valid certificates and updated Declaration of Conformity?
A: Absolutely. We can promptly provide valid certification documents (including FDA registration, CE certificate, ISO 13485 certification, etc.) and the latest updated Declaration of Conformity (DoC) upon request. All documents are officially issued and recognized by relevant regulatory authorities to meet your import and registration needs.
Q:Do you have experience registering products in our country?
A:We have extensive experience in product registration across various countries and regions worldwide. Our professional regulatory team is familiar with the local registration procedures, documentation requirements, and regulatory frameworks of different markets. We can provide full support throughout the registration process, including document preparation, technical communication, and coordination with local authorities to streamline the registration process for you.
Q:What is your quality control process from raw material to finished goods?
A:Our quality control process is comprehensive and covers the entire supply chain:
Incoming Raw Material Inspection: All raw materials are tested against specified standards (e.g., purity, biocompatibility) with COA verification before entering production;
In-Process Quality Control: Key production stages are monitored in real-time, with sampling inspections for critical parameters to prevent deviations;
Finished Goods Inspection: 100% visual inspection and random sampling for performance, sterility (if applicable), packaging integrity, and labeling compliance;
Post-Production Traceability: Each batch is assigned a unique traceability code, linking raw materials, production records, and test results for full traceability.
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