K014019 is an FDA 510(k) clearance for the NEUROTECH MEDISTIM PLUS, TYPE 291. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on July 11, 2002, 217 days after receiving the submission on December 6, 2001.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K014019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2001 |
| Decision Date | July 11, 2002 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |