K202861 is an FDA 510(k) clearance for the Needle Stimulator. This device is classified as a Stimulator, Electro-acupuncture.
Submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on August 27, 2021, 333 days after receiving the submission on September 28, 2020.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K202861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2020 |
| Decision Date | August 27, 2021 |
| Days to Decision | 333 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | BWK - Stimulator, Electro-acupuncture |
| Device Class | - |