The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Neurotech Plus.
| Device ID | K112258 |
| 510k Number | K112258 |
| Device Name: | NEUROTECH PLUS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| 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 | GZJ |
| Subsequent Product Code | IPF |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-05 |
| Decision Date | 2012-01-09 |
| Summary: | summary |