510(k) K021100
K021100 is an FDA 510(k) premarket notification submitted by Empi for the device "300 PV COMPLETE ELECTROTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 18, 2002. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Empi has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2002
- Date Received
- April 4, 2002
- 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