Medi Pneumatic Compression System (pcs)-genius (Model 652)

Sleeve, Limb, Compressible

Medi USA, L.P.

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).

Pre-market Notification Details

Device IDK221654
510k NumberK221654
Device Name:Medi Pneumatic Compression System (pcs)-genius (Model 652)
ClassificationSleeve, Limb, Compressible
Applicant medi USA, L.P. 6481 Franz Warner Parkway Whitsett,  NC  27377 -9214
ContactMoses Lipshaw
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-06-07
Decision Date2022-07-07

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