510(k) K230164
K230164 is an FDA 510(k) premarket notification submitted by Changsha Yuwen Medical Equipment Co., Ltd. for the device "TENS and EMS Stimulation (OTC)". The FDA issued a decision of Substantially Equivalent on Apr 10, 2023. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Changsha Yuwen Medical Equipment Co., Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 10, 2023
- Date Received
- Jan 20, 2023
- 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