The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Modification To:kneehab Xp Conductive Garment, Model 411.
| Device ID | K092793 |
| 510k Number | K092793 |
| Device Name: | MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 |
| Classification | Electrode, Cutaneous |
| Applicant | BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, WEST Galway, IE |
| Contact | Anne-marie Keenan |
| Correspondent | Anne-marie Keenan BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, WEST Galway, IE |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-11 |
| Decision Date | 2009-12-07 |
| Summary: | summary |