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HANDICARE USA, INC.

Last updated September 17, 2026

Information

Country: US
Address: 10888 Metro Ct., Maryland Heights, MO, 63043
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007802293
DUNS Number: 800145836

Catalogue (603)

Page 8 of 13

Device	Model / Reference	Registries	Class	Status
Handicare	8H4401	FDA UDI	Class I	Active
Handicare	537120	FDA UDI	Class I	Active
Handicare	600028	FDA UDI	Class I	Active
Handicare	402500	FDA UDI	Class I	Active
Handicare	8E4230	FDA UDI	Class I	Active
Handicare	5208E4600-B	FDA UDI	Class I	Active
Handicare	360408	FDA UDI	Class I	Active
Handicare	402512	FDA UDI	Class I	Active
Handicare	400601	FDA UDI	Class I	Active
Handicare	8H1200	FDA UDI	Class I	Active
Handicare	517330	FDA UDI	Class I	Active
Handicare	8H1221	FDA UDI	Class I	Active
Handicare	280079	FDA UDI	Class I	Active
Handicare	510427	FDA UDI	Class I	Active
Handicare	507940	FDA UDI	Class I	Active
Handicare	400104	FDA UDI	Class I	Active
Handicare	600018	FDA UDI	Class I	Active
Handicare	8H1520	FDA UDI	Class I	Active
Handicare	520517420-B	FDA UDI	Class I	Active
Handicare	360406	FDA UDI	Class I	Active
Handicare	400073	FDA UDI	Class I	Active
Handicare	8H2400	FDA UDI	Class I	Active
Handicare	510423-A	FDA UDI	Class I	Active
Handicare	520600275	FDA UDI	Class I	Active
Handicare	400030	FDA UDI	Class I	Active
Handicare	400106	FDA UDI	Class I	Active
Handicare	5208A1600-S	FDA UDI	Class I	Active
Handicare	5208E4432-S-1	FDA UDI	Class I	Active
Handicare	323228	FDA UDI	Class I	Active
Handicare	400000	FDA UDI	Class I	Active
Handicare	8C0300	FDA UDI	Class I	Active
Handicare	323177	FDA UDI	Class I	Active
Handicare	8H4201	FDA UDI	Class I	Active
Handicare	600015	FDA UDI	Class I	Active
Handicare	323417	FDA UDI	Class I	Active
Handicare	230530	FDA UDI	Class I	Active
Handicare	517310	FDA UDI	Class I	Active
Handicare	402510	FDA UDI	Class I	Active
Handicare	547810S	FDA UDI	Class I	Active
Handicare	8D2530	FDA UDI	Class I	Active
Handicare	323251	FDA UDI	Class I	Active
Handicare	507782	FDA UDI	Class I	Active
Handicare	600275	FDA UDI	Class I	Active
Handicare	400079	FDA UDI	Class I	Active
Handicare	329150	FDA UDI	Class I	Active
Handicare	280070	FDA UDI	Class I	Active
Handicare	510425	FDA UDI	Class I	Active
Handicare	8H4431	FDA UDI	Class I	Active
Handicare	8E4701	FDA UDI	Class I	Active
Handicare	8E4202	FDA UDI	Class I	Active

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 3, 2017	Z-2753-2018	—	terminated	Premature strap wear and breakage at maximum weight conditions (625 lbs.).
Nov 3, 2017	Z-2752-2018	—	terminated	Premature strap wear and breakage at maximum weight conditions (625 lbs.).
Sep 8, 2017	Z-0013-2018	—	terminated	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.
Mar 26, 2015	Z-1613-2015	—	terminated	Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
Apr 15, 2014	Z-0303-2017	—	terminated	During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder.