510(k) K222867
K222867 is an FDA 510(k) premarket notification submitted by Andon Health Co, Ltd. for the device "AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)". The FDA issued a decision of Substantially Equivalent on December 21, 2022. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Andon Health Co, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2022
- Date Received
- September 22, 2022
- Clearance Type
- Abbreviated
- 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
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES