510(k) K911066
K911066 is an FDA 510(k) premarket notification submitted by M. D. Supply, Inc. for the device "COMFORTRON PT (TENS)". The FDA issued a decision of Substantially Equivalent on February 7, 1992. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. M. D. Supply, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1992
- Date Received
- March 11, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Neuromuscular, External Functional
- Device Class
- Class II
- Regulation Number
- 882.5810
- Review Panel
- NE
- Submission Type