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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 4 of 13

Device	Model / Reference	Registries	Class	Status
Handicare	5208A1300-S	FDA UDI	Class I	Active
Handicare	400608A	FDA UDI	Class I	Active
Handicare	341512	FDA UDI	Class I	Active
Handicare	400081	FDA UDI	Class I	Active
Handicare	8D1520	FDA UDI	Class I	Active
Handicare	8H1501	FDA UDI	Class I	Active
Handicare	520517420-S	FDA UDI	Class I	Active
Handicare	517430	FDA UDI	Class I	Active
Handicare	8H2501	FDA UDI	Class I	Active
Handicare	8D2230	FDA UDI	Class I	Active
Handicare	537130	FDA UDI	Class I	Active
Handicare	400008	FDA UDI	Class I	Active
Handicare	537640	FDA UDI	Class I	Active
Handicare	280425	FDA UDI	Class I	Active
Handicare	400087	FDA UDI	Class I	Active
Handicare	8E4732	FDA UDI	Class I	Active
Handicare	402503	FDA UDI	Class I	Active
Handicare	230010	FDA UDI	Class I	Active
Handicare	517405	FDA UDI	Class I	Active
Handicare	341600	FDA UDI	Class I	Active
Handicare	324207	FDA UDI	Class I	Active
Handicare	8E4500	FDA UDI	Class I	Active
Handicare	8H4501	FDA UDI	Class I	Active
Handicare	8H4301	FDA UDI	Class I	Active
Handicare	8B0400	FDA UDI	Class I	Active
Handicare	8H2300	FDA UDI	Class I	Active
Handicare	8H2401	FDA UDI	Class I	Active
Handicare	360752	FDA UDI	Class I	Active
Handicare	323137	FDA UDI	Class I	Active
Handicare	400086	FDA UDI	Class I	Active
Handicare	400047	FDA UDI	Class I	Active
Handicare	8H1600	FDA UDI	Class I	Active
Handicare	323201	FDA UDI	Class I	Active
Handicare	400034	FDA UDI	Class I	Active
Handicare	8H2200	FDA UDI	Class I	Active
Handicare	547103	FDA UDI	Class I	Active
Handicare	400001	FDA UDI	Class I	Active
Handicare	323257	FDA UDI	Class I	Active
Handicare	510429	FDA UDI	Class I	Active
Handicare	8A2200	FDA UDI	Class I	Active
Handicare	8H4630	FDA UDI	Class I	Active
Handicare	8E4300	FDA UDI	Class I	Active
Handicare	547080	FDA UDI	Class I	Active
Handicare	600250	FDA UDI	Class I	Active
Handicare	8H1421	FDA UDI	Class I	Active
Handicare	520600250	FDA UDI	Class I	Active
Handicare	8H1521	FDA UDI	Class I	Active
Handicare	8H4300	FDA UDI	Class I	Active
Handicare	329181	FDA UDI	Class I	Active
Handicare	8H4731	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.