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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 5 of 13
DeviceModel / ReferenceRegistriesClassStatus
Handicare 8H4330
FDA UDI
Class IActive
Handicare 323231
FDA UDI
Class IActive
Handicare 507788
FDA UDI
Class IActive
Handicare 324205
FDA UDI
Class IActive
Handicare 521044
FDA UDI
Class IActive
Handicare 230200
FDA UDI
Class IActive
Handicare 280073
FDA UDI
Class IActive
Handicare 324223
FDA UDI
Class IActive
Handicare 8D2630
FDA UDI
Class IActive
Handicare 400275
FDA UDI
Class IActive
Handicare 510422
FDA UDI
Class IActive
Handicare 341522
FDA UDI
Class IActive
Handicare 329103
FDA UDI
Class IActive
Handicare 5208A1400-S
FDA UDI
Class IActive
Handicare 8H4531
FDA UDI
Class IActive
Handicare 537150
FDA UDI
Class IActive
Handicare 341620
FDA UDI
Class IActive
Handicare 323150V
FDA UDI
Class IActive
Handicare 8A2230
FDA UDI
Class IActive
Handicare 600200
FDA UDI
Class IActive
Handicare 8B0300
FDA UDI
Class IActive
Handicare 280075
FDA UDI
Class IActive
Handicare 547116
FDA UDI
Class IActive
Handicare 537121
FDA UDI
Class IActive
Handicare 8E4501
FDA UDI
Class IActive
Handicare 547111
FDA UDI
Class IActive
Handicare 341505
FDA UDI
Class IActive
Handicare 303093
FDA UDI
Class IUnknown
Handicare 8E4431
FDA UDI
Class IActive
Handicare 323246M
FDA UDI
Class IActive
Handicare 537605
FDA UDI
Class IActive
Handicare 323427
FDA UDI
Class IActive
Handicare 507787
FDA UDI
Class IActive
Handicare 323119
FDA UDI
Class IActive
Handicare 400071
FDA UDI
Class IActive
Handicare 400048
FDA UDI
Class IActive
Handicare 450013
FDA UDI
Class IActive
Handicare 520537340-B-1
FDA UDI
Class IActive
Handicare 527550
FDA UDI
Class IActive
Handicare 323127V
FDA UDI
Class IActive
Handicare 280072
FDA UDI
Class IActive
Handicare 521045
FDA UDI
Class IActive
Handicare 8H4331
FDA UDI
Class IActive
Handicare 400032
FDA UDI
Class IActive
Handicare 400603
FDA UDI
Class IActive
Handicare 507784
FDA UDI
Class IActive
Handicare 8H1301
FDA UDI
Class IActive
Handicare 8A2400
FDA UDI
Class IActive
Handicare 5208A1200-S
FDA UDI
Class IActive
Handicare 450007
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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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.