K200636 is an FDA 510(k) clearance for the AXUS ES-5 Electro-Acupuncture Device. This device is classified as a Stimulator, Electro-acupuncture.
Submitted by Lhasa Oms, Inc. (Weymouth, US). The FDA issued a Cleared decision on February 3, 2021, 330 days after receiving the submission on March 10, 2020.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K200636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2020 |
| Decision Date | February 03, 2021 |
| Days to Decision | 330 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | BWK - Stimulator, Electro-acupuncture |
| Device Class | - |