510(k) K903711
K903711 is an FDA 510(k) premarket notification submitted by Advanced Rehabilitative Technology, Inc. for the device "RHEOLOGIC I". The FDA issued a decision of Substantially Equivalent on January 16, 1991. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Advanced Rehabilitative Technology, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 1991
- Date Received
- August 14, 1990
- 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