510(k) K000114
K000114 is an FDA 510(k) premarket notification submitted by Rs Medical for the device "RS-4M+MUSCLE STIMULATOR". The FDA issued a decision of Substantially Equivalent on August 10, 2000. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Rs Medical has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2000
- Date Received
- January 14, 2000
- 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