MEDRELIEF SE SERIES - Se-200
510(k) K030998
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030998 | Date10 Oct 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The MedRelief SE Series (Models SE-50, SE-100, SE-200, SE-300) is classified as a Microcurrent TENS Device (21 CFR 882.5890), an Interferential Stimulator (21 CFR 890.5850), and a Powered Muscle Stimulator (21 CFR 890.5850). These devices deliver electrical stimulation for therapeutic purposes, including modulation of pain signals and muscle activation via low-intensity currents. The SE Series operates in subthreshold and interferential modes to target chronic pain and facilitate recovery in post-surgical or post-traumatic conditions. Each model varies in output parameters, enabling customisation for patient-specific needs.
The MedRelief SE Series is supplied as a reusable medical device, intended for clinical use in physical medicine settings. Sterility is not required, but proper cleaning and maintenance protocols must be followed to ensure device integrity and patient safety. The devices are FDA-cleared under a 510(k) submission (K030998) and fall under the Physical Medicine advisory committee classification. Models SE-50, SE-100, SE-200, and SE-300 are differentiated by their output specifications, with no MRI safety restrictions noted. Storage should comply with manufacturer guidelines to preserve functionality.
Other devices from Healthonics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What therapeutic applications does the MedRelief SE Series support?
The MedRelief SE Series is designed to modulate pain signals and activate muscles using low-intensity electrical currents. It operates in subthreshold and interferential modes, making it suitable for managing chronic pain and aiding recovery in post-surgical or post-traumatic conditions. The varying output parameters across models (SE-50, SE-100, SE-200, SE-300) allow clinicians to tailor treatment to individual patient needs.
How is the MedRelief SE Series supplied and what are its sterility requirements?
The MedRelief SE Series is supplied as a reusable medical device intended for clinical use in physical medicine settings. Sterility is not required for this device, but it must be cleaned and maintained according to manufacturer guidelines to ensure device integrity and patient safety. Proper care extends the device’s lifespan and reliability.
Are the MedRelief SE Series models compatible with MRI environments?
The MedRelief SE Series does not have any noted MRI safety restrictions. However, it is always recommended to consult the manufacturer’s guidelines and local MRI safety protocols before use in an MRI environment to ensure patient and device safety.
How do the models SE-50, SE-100, SE-200, and SE-300 differ?
The models in the MedRelief SE Series are differentiated by their output specifications, which allow for customisation based on patient-specific needs. While the exact output parameters are not detailed here, the varying models enable clinicians to select the appropriate device for different pain management or muscle activation requirements.
What regulatory pathway does the MedRelief SE Series follow?
The MedRelief SE Series is FDA-cleared under a 510(k) submission (K030998) and is classified under the Physical Medicine advisory committee. The device is determined to be substantially equivalent to a legally marketed predicate, ensuring compliance with U.S. regulatory standards for electrical stimulation devices.