The following data is part of a premarket notification filed by Medi Usa, Lp with the FDA for Medi Pneumatic Compression System (pcs) – Brio (model 651).
| Device ID | K183631 |
| 510k Number | K183631 |
| Device Name: | Medi Pneumatic Compression System (pcs) – Brio (Model 651) |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Medi USA, LP 6481 Franz Warner Pkwy. Whitsett, NC 27377 |
| Contact | Glenn Anderson |
| Correspondent | Mark Job 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 | 2018-12-26 |
| Decision Date | 2019-01-25 |
| Summary: | summary |