510(k) K962462
K962462 is an FDA 510(k) premarket notification submitted by Smith And Nephew Donjoy, Inc. for the device "MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR". The FDA issued a decision of Substantially Equivalent on Sep 23, 1996. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Smith And Nephew Donjoy, Inc. has 14 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 23, 1996
- Date Received
- Jun 25, 1996
- 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
- 510(k)