The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Neurotech Medistim Plus, Type 291.
| Device ID | K014019 |
| 510k Number | K014019 |
| Device Name: | NEUROTECH MEDISTIM PLUS, TYPE 291 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway, IE |
| Contact | Michelle Sawyer |
| Correspondent | Michelle Sawyer BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway, IE |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-06 |
| Decision Date | 2002-07-11 |
| Summary: | summary |