K220998 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator, Model: KTR-405. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Shenzhen Kentro Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 24, 2022, 142 days after receiving the submission on April 4, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5890. Temporary Relief Of Pain Due To Sore/aching Muscles.
| 510(k) Number | K220998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2022 |
| Decision Date | August 24, 2022 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| 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 |