510(k) K060032
K060032 is an FDA 510(k) premarket notification submitted by Restorative Therapies, Inc. for the device "RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053". The FDA issued a decision of Substantially Equivalent on March 10, 2006. 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
- March 10, 2006
- Date Received
- January 5, 2006
- Clearance Type
- Special
- 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