Mercury Medical Expiratory Resistance Exerciser, Resistex
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Resistex EUDAMEDFDA UDI
- Generic Name
- Incentive spirometer FDA UDI
- Device Name
- Resistex EUDAMED
- Model / Reference
- 10-37000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043370001 EUDAMEDFDA UDI
- Basic UDI-DI
- 0641043RENJ EUDAMED
- FDA Product Code
- BWF FDA 510(k)FDA UDI
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
- GMDN Term
- Incentive spirometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5690 FDA 510(k)
- Regulation Number
- 868.5690 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The Mercury Medical Expiratory Resistance Exerciser Resitex is a therapeutic incentive device designed to assist patients in improving respiratory function through controlled expiratory resistance exercises. Classified as a spirometer under regulatory nomenclature, it provides measurable resistance to encourage deeper breathing and lung expansion, aiding in pulmonary rehabilitation and postoperative recovery.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as anesthesia care. It requires no specific sterility beyond standard cleaning protocols between patient use. The Resitex operates within Class II regulatory classification (FDA 510(k) and MDR) and is authorized for distribution under the product code BWF. No MRI safety information or additional size specifications are provided in the regulatory data.
Frequently asked questions
What is the primary clinical purpose of the Mercury Medical Expiratory Resistance Exerciser, Resitex, and how does it help patients?
The Mercury Medical Expiratory Resistance Exerciser, Resitex, is designed to improve respiratory function by providing controlled expiratory resistance during breathing exercises. It encourages deeper breathing and lung expansion, which is particularly beneficial for patients undergoing pulmonary rehabilitation or postoperative recovery. By creating measurable resistance, it helps patients strengthen their respiratory muscles and enhance overall lung capacity.
Is the Resitex device single-use or reusable, and what cleaning requirements apply?
The Resitex is a reusable medical instrument intended for clinical use, such as in anesthesia care. While it does not require specialized sterility beyond standard protocols, it must be thoroughly cleaned between patient uses to maintain hygiene and prevent cross-contamination.
What regulatory pathway was followed for the approval of this device, and what classification does it hold?
The Resitex was authorized through the FDA 510(k) pathway, classified as substantially equivalent to a predicate device. It falls under Class II regulatory classification and is distributed under product code BWF, which aligns with spirometers and therapeutic incentive devices. Additionally, it complies with the MDR (Medical Device Regulation) in its regulatory framework.
Are there any specific size variations or models available for the Resitex device?
The provided regulatory data does not specify any distinct size variations or model numbers for the Resitex. However, it is categorized as a spirometer under regulatory nomenclature, implying a standardized design for controlled expiratory resistance exercises. For precise sizing or model details, refer to the manufacturer’s product documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K954492 | Class II | Active |
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Manufacturer
- Manufacturer
- Mercury Medical
Sources (3)
- FDA 510(k) K954492 24 fields · synced Oct 6, 2026
- FDA UDI 72b17b66-2e7b-484e-9312-c321163f2fe3 34 fields · synced May 30, 2026
- EUDAMED 482719b6-4454-4426-87c4-5ee7d827b25b 61 fields · synced Jul 15, 2026