510(k) K130052
K130052 is an FDA 510(k) premarket notification submitted by Tone-A-Matic International, Inc. for the device "TONE-A-MATIC". The FDA issued a decision of Substantially Equivalent on December 20, 2013. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Tone-A-Matic International, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2013
- Date Received
- January 9, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type