FDA Device Entity Profile: Handicare USA, Inc.

Known Identifiers & Locations

FEI Numbers 3007802293

Owner Operator Numbers 10029966

Locations Covered Maryland Heights, MO, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3007802293	Handicare USA, Inc.	Maryland Heights, MO, US	Complaint File Establishment per 21 CFR 820.198	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0013-2018	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered Reason: During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied component that was not to specification. If the strap wears during use there is a potential risk for the person being supported by the lift to drop.	2017-09-08	Terminated	View Details

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