510(k) K901902
K901902 is an FDA 510(k) premarket notification submitted by Microcurrent Research, Inc. for the device "ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE". The FDA issued a decision of Substantially Equivalent on Oct 9, 1990. The device falls under product code NUW (Stimulator, Muscle, Powered, Dental), a Class II device regulated under 21 CFR 890.5850. Microcurrent Research, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 9, 1990
- Date Received
- Apr 27, 1990
- 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.