The following data is part of a premarket notification filed by Medi Usa, L.p. with the FDA for Medi Pneumatic Compression System (pcs)-genius (model 652).
| Device ID | K221654 |
| 510k Number | K221654 |
| Device Name: | Medi Pneumatic Compression System (pcs)-genius (Model 652) |
| Classification | Sleeve, Limb, Compressible |
| Applicant | medi USA, L.P. 6481 Franz Warner Parkway Whitsett, NC 27377 -9214 |
| Contact | Moses Lipshaw |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-06-07 |
| Decision Date | 2022-07-07 |