510(k) K013768
K013768 is an FDA 510(k) premarket notification submitted by Theratech, Inc. for the device "POWERED MUSCLE STIMULATOR". The FDA issued a decision of Substantially Equivalent on July 3, 2002. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Theratech, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2002
- Date Received
- November 13, 2001
- 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