K222867 is an FDA 510(k) clearance for the AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS). This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on December 21, 2022, 90 days after receiving the submission on September 22, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890. Temporary Relief Of Pain Due To Sore/aching Muscles.
| 510(k) Number | K222867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2022 |
| Decision Date | December 21, 2022 |
| Days to Decision | 90 days |
| Submission Type | Abbreviated |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |
| Definition | Temporary Relief Of Pain Due To Sore/aching Muscles |