510(k) K083105
K083105 is an FDA 510(k) premarket notification submitted by Bio-Medical Research, Ltd. for the device "KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411". The FDA issued a decision of Substantially Equivalent on Jul 24, 2009. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Bio-Medical Research, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2009
- Date Received
- Oct 20, 2008
- 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