The following data is part of a premarket notification filed by Recovery Force Llc with the FDA for Rf1400 Active Compression Wrap.
| Device ID | K162481 |
| 510k Number | K162481 |
| Device Name: | RF1400 Active Compression Wrap |
| Classification | Sleeve, Limb, Compressible |
| Applicant | RECOVERY FORCE LLC 12175 VISIONARY WAY, SUITE 540 Fishers, IN 46038 |
| Contact | Jeff Schwegman |
| Correspondent | Deborah Lavoie Grayeski M.SQUARED ASSOCIATES 575 8TH AVE New York, NY 10018 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-06 |
| Decision Date | 2017-02-16 |
| Summary: | summary |