The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Baxolve Xp Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298.
| Device ID | K082190 |
| 510k Number | K082190 |
| Device Name: | BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 |
| 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 |
| Subsequent Product Code | GXY |
| Subsequent Product Code | IQE |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-04 |
| Decision Date | 2009-03-11 |
| Summary: | summary |