510(k) K220150
K220150 is an FDA 510(k) premarket notification submitted by Hong Qiangxing (Shenzhen) Electronics Limited for the device "TENS & PMS (Model: SM9126)". The FDA issued a decision of Substantially Equivalent on February 17, 2022. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Hong Qiangxing (Shenzhen) Electronics Limited has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2022
- Date Received
- January 19, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES