K081943 is an FDA 510(k) clearance for the MODEL ES-130. This device is classified as a Stimulator, Electro-acupuncture.
Submitted by Ito Co., Ltd. (Richardson, US). The FDA issued a Cleared decision on November 24, 2008, 139 days after receiving the submission on July 8, 2008.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K081943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2008 |
| Decision Date | November 24, 2008 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | BWK - Stimulator, Electro-acupuncture |
| Device Class | - |