K201290 is an FDA 510(k) clearance for the Medline DeNovo 4Pro Electrical Stimulation Device. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Medline Industries, Inc. (Northfield, US). The FDA issued a Cleared decision on September 21, 2020, 130 days after receiving the submission on May 14, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K201290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2020 |
| Decision Date | September 21, 2020 |
| Days to Decision | 130 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 |