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 |
B547RF14217 | K203052 | 000 |
B547RF14208 | K203052 | 000 |
B547RF14100 | K203052 | 000 |
B547RF14227 | K203052 | 000 |
B547RF14230 | K203052 | 000 |