Device Information
The M-Wave is designed as a powered muscle stimulator, specifically for muscle re-education, preventing muscle atrophy due to disuse, improving local blood circulation, and enhancing muscle motion range. Additionally, it aids in relaxing muscle spasms, making it versatile for various rehabilitation purposes.
Indications
The M-Wave device is intended for:
- Muscle re-education
- Prevention of disuse atrophy
- Increasing local blood circulation
- Maintaining or increasing range of motion
- Relaxation of muscle spasms
Intended Use
This device is designed for individuals who require muscle stimulation therapy. It can be used by medical professionals in clinical settings or prescribed for home use. Its primary users are patients needing muscle rehabilitation, such as those recovering from injuries or surgeries.
Availability
The device is available by prescription only (21 CFR 801 Subpart D).
Regulatory Information
- Regulation Number: 21 CFR 890.5850
- Regulatory Class: Class II
- Product Code: IPF
- 510(k) Number: K233485
- The device is subject to the Quality System regulations (21 CFR Part 820), ensuring compliance with FDA manufacturing standards, nonconformance product management, and preventive actions.
Manufacturer Information
- Name: Zynex Medical Inc.
- Address: 9655 Maroon Circle, Englewood, Colorado 80112
- Contact Person: Harrison Tanksley, Senior Electrical Engineer
Implications
The M-Wave is expected to benefit patients by rehabilitating muscle functions. Its advanced features in muscle stimulation can help in various therapeutic contexts, enhancing recovery outcomes.
References
- M-Wave. Zynex Medical Inc. 510k Number K233485. FDA Summary Link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233485
- https://www.zynex.com/
- https://www.zynex.com/wp-content/uploads/2024/03/M-Wave-Brochure-Rev-5.pdf
Medevx 