The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Avivafix Conductive Garment-knee/shoulder/upper Back, Type 40.
| Device ID | K102614 |
| 510k Number | K102614 |
| Device Name: | AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 |
| Classification | Electrode, Cutaneous |
| Applicant | BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST Galway, IE Ei |
| Contact | Anne-marie Keenan |
| Correspondent | Anne-marie Keenan BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST Galway, IE Ei |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-10 |
| Decision Date | 2011-06-03 |
| Summary: | summary |