510(k) K220997
K220997 is an FDA 510(k) premarket notification submitted by Zmi Elecronics , Ltd. for the device "Wireless TENS/EMS, Bruno, Aela". The FDA issued a decision of Substantially Equivalent on Sep 1, 2022. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 1, 2022
- Date Received
- Apr 4, 2022
- 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