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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 2 of 13
DeviceModel / ReferenceRegistriesClassStatus
Handicare 8H1620
FDA UDI
Class IActive
Handicare 323650
FDA UDI
Class IActive
Handicare 8D4730
FDA UDI
Class IActive
Handicare 8E4730
FDA UDI
Class IActive
Handicare 450001
FDA UDI
Class IActive
Handicare 8H4701
FDA UDI
Class IActive
Handicare 8E4630
FDA UDI
Class IActive
Handicare 402455
FDA UDI
Class IActive
Handicare 324204
FDA UDI
Class IActive
Handicare 510430
FDA UDI
Class IActive
Handicare 537106
FDA UDI
Class IActive
Handicare 400265
FDA UDI
Class IActive
Handicare 323215
FDA UDI
Class IActive
Handicare 341516
FDA UDI
Class IActive
Handicare 507720
FDA UDI
Class IActive
Handicare 329104
FDA UDI
Class IActive
Handicare 400084
FDA UDI
Class IActive
Handicare 360935
FDA UDI
Class IActive
Handicare 5208A1500-S
FDA UDI
Class IActive
Handicare 8A2500
FDA UDI
Class IActive
Handicare 323649
FDA UDI
Class IActive
Handicare 341510
FDA UDI
Class IActive
Handicare 323149
FDA UDI
Class IActive
Handicare 341528
FDA UDI
Class IActive
Handicare 507818
FDA UDI
Class IActive
Handicare 600071
FDA UDI
Class IActive
Handicare 8A1200
FDA UDI
Class IActive
Handicare 547051
FDA UDI
Class IActive
Handicare 507905
FDA UDI
Class IActive
Handicare 303075
FDA UDI
Class IUnknown
Handicare 8H4700
FDA UDI
Class IActive
Handicare 521046
FDA UDI
Class IActive
Handicare 400013
FDA UDI
Class IActive
Handicare 600082
FDA UDI
Class IActive
Handicare 8E4200
FDA UDI
Class IActive
Handicare 400078
FDA UDI
Class IActive
Handicare 400026
FDA UDI
Class IActive
Handicare 341515
FDA UDI
Class IActive
Handicare 323450
FDA UDI
Class IActive
Handicare 360760
FDA UDI
Class IActive
Handicare 8H4400
FDA UDI
Class IActive
Handicare 450006
FDA UDI
Class IActive
Handicare 230540
FDA UDI
Class IActive
Handicare 520547060-2
FDA UDI
Class IActive
Handicare 400019
FDA UDI
Class IActive
Handicare 520547060-10
FDA UDI
Class IActive
Handicare 8H2530
FDA UDI
Class IActive
Handicare 520547810-E
FDA UDI
Class IActive
Handicare 5208E4731-S-1
FDA UDI
Class IActive
Handicare 370871
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.