510(k) K103366
K103366 is an FDA 510(k) premarket notification submitted by Restorative Therapies, Inc. for the device "RT600". The FDA issued a decision of Substantially Equivalent on April 4, 2011. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Restorative Therapies, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2011
- Date Received
- November 16, 2010
- 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