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HANDICARE USA, INC.

US

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 6 of 13
DeviceModel / ReferenceRegistriesClassStatus
Handicare 547810
FDA UDI
Class IActive
Handicare 280078
FDA UDI
Class IActive
Handicare 329180
FDA UDI
Class IActive
Handicare 8D4330
FDA UDI
Class IActive
Handicare 8B0500
FDA UDI
Class IActive
Handicare 402515
FDA UDI
Class IActive
Handicare 8E4331
FDA UDI
Class IActive
Handicare 341503
FDA UDI
Class IActive
Handicare 537140
FDA UDI
Class IActive
Handicare 400036
FDA UDI
Class IActive
Handicare 8A2300
FDA UDI
Class IActive
Handicare 517550
FDA UDI
Class IActive
Handicare 8A4400
FDA UDI
Class IActive
Handicare 323217
FDA UDI
Class IActive
Handicare 8A4200
FDA UDI
Class IActive
Handicare 5208A1520-H-1
FDA UDI
Class IActive
Handicare 520537120-S
FDA UDI
Class IActive
Handicare 329190
FDA UDI
Class IActive
Handicare 303080
FDA UDI
Class IUnknown
Handicare 510439
FDA UDI
Class IActive
Handicare 507811
FDA UDI
Class IActive
Handicare 8D2730
FDA UDI
Class IActive
Handicare 5208E4201-B-1
FDA UDI
Class IActive
Handicare 8A1520
FDA UDI
Class IActive
Handicare 600080
FDA UDI
Class IActive
Handicare 400015
FDA UDI
Class IActive
Handicare 520517520-1
FDA UDI
Class IActive
Handicare 230030
FDA UDI
Class IActive
Handicare 520521046-B-1
FDA UDI
Class IActive
Handicare 360982
FDA UDI
Class IActive
Handicare 280403
FDA UDI
Class IActive
Handicare 520547080-10
FDA UDI
Class IActive
Handicare 600032
FDA UDI
Class IActive
Handicare 9Y4901
FDA UDI
Class IActive
Handicare 8H2430
FDA UDI
Class IActive
Handicare 8C0400
FDA UDI
Class IActive
Handicare 402511
FDA UDI
Class IActive
Handicare 520537330-B-1
FDA UDI
Class IActive
Handicare 324202
FDA UDI
Class IActive
Handicare 8E4302
FDA UDI
Class IActive
Handicare 8E4531
FDA UDI
Class IActive
Handicare 8E4532
FDA UDI
Class IActive
Handicare 8H2231
FDA UDI
Class IActive
Handicare 520580500-B
FDA UDI
Class IActive
Handicare 507814
FDA UDI
Class IActive
Handicare 507910
FDA UDI
Class IActive
Handicare 600036
FDA UDI
Class IActive
Handicare 8E4301
FDA UDI
Class IActive
Handicare 600034
FDA UDI
Class IActive
Handicare 8E4731
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Nov 3, 2017Z-2753-2018—terminated

Premature strap wear and breakage at maximum weight conditions (625 lbs.).

Nov 3, 2017Z-2752-2018—terminated

Premature strap wear and breakage at maximum weight conditions (625 lbs.).

Sep 8, 2017Z-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, 2015Z-1613-2015—terminated

Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.

Apr 15, 2014Z-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.