K130052 is an FDA 510(k) clearance for the TONE-A-MATIC. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Tone-A-Matic International, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on December 20, 2013, 345 days after receiving the submission on January 9, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K130052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2013 |
| Decision Date | December 20, 2013 |
| Days to Decision | 345 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 |