510(k) K770252
K770252 is an FDA 510(k) premarket notification submitted by Myo-Tronics Research, Inc. for the device "MONITOR, MYO, MODEL J3". The FDA issued a decision of Substantially Equivalent on Feb 18, 1977. The device falls under product code NUW (Stimulator, Muscle, Powered, Dental), a Class II device regulated under 21 CFR 890.5850. Myo-Tronics Research, Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 18, 1977
- Date Received
- Feb 9, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered, Dental
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- DE
- Submission Type
- 510(k)
Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.