Submission Details
| 510(k) Number | K130768 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 20, 2013 |
| Decision Date | August 16, 2013 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
K130768 is an FDA 510(k) clearance for the JIAJIAN CMN STIMULATOR, a Stimulator, Electro-acupuncture, submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 16, 2013, 149 days after receiving the submission on March 20, 2013. This device falls under the Neurology review panel.
| 510(k) Number | K130768 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 20, 2013 |
| Decision Date | August 16, 2013 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | BWK — Stimulator, Electro-acupuncture |
| Device Class | — |