The following data is part of a premarket notification filed by Eezcare Medical Corp with the FDA for Ezlymph, Ezlymph M.
Device ID | K193662 |
510k Number | K193662 |
Device Name: | Ezlymph, Ezlymph M |
Classification | Sleeve, Limb, Compressible |
Applicant | Eezcare Medical Corp NO. 3-1, Minquan St New Taipei City 236, Taipei, TW 23679 |
Contact | Michelle C Mitchell |
Correspondent | John Gillespy FDA 510k Consultants, LLC 1100 Del Lago Cir, Ste 104 Palm Beach Gardens, FL 33410 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-31 |
Decision Date | 2021-02-11 |