The following data is part of a premarket notification filed by Recovery Force, Llc with the FDA for Movement And Compressions System (the Mac System).
| Device ID | K203052 |
| 510k Number | K203052 |
| Device Name: | Movement And Compressions System (the MAC System) |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Recovery Force, LLC 10022 Lantern Rd., Suite 100 Fishers, IN 46037 |
| Contact | Jeff Schwegman |
| Correspondent | Deborah Lavoie Grayeski M Squared Associates 127 West 30th Street, 9th Floor New York, NY 10001 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-07 |
| Decision Date | 2021-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B547RF14300 | K203052 | 000 |
| B547RF1440211 | K203052 | 000 |
| B547RF1440221 | K203052 | 000 |
| B547RF1440231 | K203052 | 000 |
| B547RF14230 | K203052 | 000 |
| B547RF14227 | K203052 | 000 |
| B547RF14100 | K203052 | 000 |
| B547RF14208 | K203052 | 000 |
| B547RF14217 | K203052 | 000 |
| B547RF1440201 | K203052 | 000 |