510(k) K813533
K813533 is an FDA 510(k) premarket notification submitted by Myo-Tronics Research, Inc. for the device "ELECTRIC MUSCLE STIMULATOR". The FDA issued a decision of Substantially Equivalent on March 5, 1982. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Myo-Tronics Research, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1982
- Date Received
- December 17, 1981
- 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