FDA Device Intelligence
Home › KENPAX INTERNATIONAL LIMITED › Customed

Customed

KENPAX INTERNATIONAL LIMITED · Model 1 · UDI-DI 74895237104110

FXP
10
510(k) clearances
124
Adverse events
0
Recalls
286
Facilities

Description

Shoe cover A non-sterile device made of a non-conductive material intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.