510(k) K163166
K163166 is an FDA 510(k) premarket notification submitted by Easywell Biomedicals, Inc. for the device "EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only". The FDA issued a decision of Substantially Equivalent on Aug 11, 2017. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Easywell Biomedicals, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 11, 2017
- Date Received
- Nov 14, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
- 510(k)
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES