Ezlymph, Ezlymph M

Sleeve, Limb, Compressible

Eezcare Medical Corp

The following data is part of a premarket notification filed by Eezcare Medical Corp with the FDA for Ezlymph, Ezlymph M.

Pre-market Notification Details

Device IDK193662
510k NumberK193662
Device Name:Ezlymph, Ezlymph M
ClassificationSleeve, Limb, Compressible
Applicant Eezcare Medical Corp NO. 3-1, Minquan St New Taipei City 236, Taipei,  TW 23679
ContactMichelle C Mitchell
CorrespondentJohn Gillespy
FDA 510k Consultants, LLC 1100 Del Lago Cir, Ste 104 Palm Beach Gardens,  FL  33410
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-31
Decision Date2021-02-11

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