510(k) K091317
K091317 is an FDA 510(k) premarket notification submitted by Bio-Medical Research, Ltd. for the device "LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK". The FDA issued a decision of Substantially Equivalent on Jun 25, 2009. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Bio-Medical Research, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 25, 2009
- Date Received
- May 4, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type