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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
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EUDAMED SRN
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FDA FEI Number
3007802293
DUNS Number
800145836

Catalogue (603)

Page 11 of 13
DeviceModel / ReferenceRegistriesClassStatus
Handicare 8E4632
FDA UDI
Class IActive
Handicare 400082
FDA UDI
Class IActive
Handicare 520547070-10
FDA UDI
Class IActive
Handicare 8H2301
FDA UDI
Class IActive
Handicare 547114
FDA UDI
Class IActive
Handicare 507770
FDA UDI
Class IActive
Handicare 329184
FDA UDI
Class IActive
Handicare 400043
FDA UDI
Class IActive
Handicare 360405M
FDA UDI
Class IActive
Handicare 303070
FDA UDI
Class IUnknown
Handicare 8H1321
FDA UDI
Class IActive
Handicare 450003
FDA UDI
Class IActive
Handicare 323261
FDA UDI
Class IActive
Handicare 547081
FDA UDI
Class IActive
Handicare 323246
FDA UDI
Class IActive
Handicare 537110
FDA UDI
Class IActive
Handicare 323211
FDA UDI
Class IActive
Handicare 400607
FDA UDI
Class IActive
Handicare 280400
FDA UDI
Class IActive
Handicare 507740
FDA UDI
Class IActive
Handicare 547112
FDA UDI
Class IActive
Handicare 537620
FDA UDI
Class IActive
Handicare 517320
FDA UDI
Class IActive
Handicare 323117
FDA UDI
Class IActive
Handicare 323150M
FDA UDI
Class IActive
Handicare 520507950-B-1
FDA UDI
Class IActive
Handicare 8H4631
FDA UDI
Class IActive
Handicare 5208A4400-M
FDA UDI
Class IActive
Handicare 8A1620
FDA UDI
Class IActive
Handicare 520517150-B
FDA UDI
Class IActive
Handicare 520537610-1
FDA UDI
Class IActive
Handicare 400044
FDA UDI
Class IActive
Handicare 8D2330
FDA UDI
Class IActive
Handicare 8H1400
FDA UDI
Class IActive
Handicare 400100
FDA UDI
Class IActive
Handicare 510432
FDA UDI
Class IActive
Handicare 8A4500
FDA UDI
Class IActive
Handicare 507950
FDA UDI
Class IActive
Handicare 517520
FDA UDI
Class IActive
Handicare 8H2531
FDA UDI
Class IActive
Handicare 341511
FDA UDI
Class IActive
Handicare 8E4602
FDA UDI
Class IActive
Handicare 303073
FDA UDI
Class IUnknown
Handicare 323218
FDA UDI
Class IActive
Handicare 400007
FDA UDI
Class IActive
Handicare 341525
FDA UDI
Class IActive
Handicare 8A1700
FDA UDI
Class IActive
Handicare 8A4700
FDA UDI
Class IActive
Handicare 360985
FDA UDI
Class IActive
Handicare 8H2230
FDA UDI
Class IActive

Related Companies

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Importers

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Notified Bodies

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Authorities

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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.

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.