K220153 is an FDA 510(k) clearance for the Needle Stimulator (Model: RJNS6-1). This device is classified as a Stimulator, Electro-acupuncture.
Submitted by Bozhou Rongjian Medical Appliance Co., Ltd. (Bozhou, CN). The FDA issued a Cleared decision on March 18, 2022, 58 days after receiving the submission on January 19, 2022.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K220153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2022 |
| Decision Date | March 18, 2022 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | BWK - Stimulator, Electro-acupuncture |
| Device Class | - |