The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Lumbofix Conductive Garment, Model 420 Back.
Device ID | K091317 |
510k Number | K091317 |
Device Name: | LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST Galway, IE |
Contact | Anne-marie Keenan |
Correspondent | Anne-marie Keenan BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST Galway, IE |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-05-04 |
Decision Date | 2009-06-25 |
Summary: | summary |