K113010 is an FDA 510(k) clearance for the FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Famidoc Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 21, 2012, 437 days after receiving the submission on October 11, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K113010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2011 |
| Decision Date | December 21, 2012 |
| Days to Decision | 437 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |