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DARCO International, Inc.

US

Last updated September 17, 2026

What DARCO International, Inc. makes

DARCO International, Inc. manufactures orthotic and supportive devices for the foot, ankle, knee, wrist, and hand. These include non-customized orthotic shoes, ankle/foot orthoses, lower-limb orthosis components with mechanical resistance, cast boots, prefabricated pressure-management insoles, knee immobilizers, reusable inflatable extremity splints, and wrist/hand orthoses.

The company's devices are classified as Class I medical devices and are listed in the FDA's Unique Device Identification (FDA UDI) system. DARCO International, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does DARCO International, Inc. manufacture?

DARCO International, Inc. manufactures orthotic and supportive devices for the foot, ankle, knee, wrist, and hand, including non-customized orthotic shoes, ankle/foot orthoses, lower-limb orthosis components with mechanical resistance, cast boots, prefabricated pressure-management insoles, knee immobilizers, reusable inflatable extremity splints, and wrist/hand orthoses, as these are the device categories and example devices explicitly provided in the data.

Where is DARCO International, Inc. based?

DARCO International, Inc. is based in the United States, as stated directly in the SUMMARY section of the provided device data, which confirms the company's country as US.

In which regulatory registry are DARCO International, Inc.'s devices listed?

DARCO International, Inc.'s devices are listed in the FDA's Unique Device Identification (FDA UDI) system, as indicated in the LISTED IN field and reiterated in the SUMMARY, which specifies that the devices are included in the fda_udi registry.

How are DARCO International, Inc.'s devices classified under regulatory frameworks?

DARCO International, Inc.'s devices are classified as Class I medical devices, as explicitly stated in the DEVICE CLASSES field and confirmed in the SUMMARY, which notes that the company's devices hold this classification without implying any broader approval or certification of the company itself.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
810 Memorial Blvd W, HUNTINGTON, WV, 25701
Website
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LinkedIn
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Facebook
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Email
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Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
1000123428
DUNS Number
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Catalogue (572)

Page 2 of 12
DeviceModel / ReferenceRegistriesClassStatus
DARCO® Toe-Alignment Splint™ TAS
FDA UDI
Class IActive
Health Design Tall Leg Walker HD-LWL-MM1
FDA UDI
Class IActive
DARCO® SlimLine™ Pediatric SLP-2N
FDA UDI
Class IActive
DARCO® AirTraveler™ Walker AT4
FDA UDI
Class IActive
DARCO® DCS Plantar Fasciitis sleeve DCS-PF2-T
FDA UDI
Class IActive
Body Armor® Stirrup Walker BPT2W
FDA UDI
Class IActive
DARCO® GentleStep™ Shoe GS135MB
FDA UDI
Class IActive
POGO™ Pulsus PGP075G
FDA UDI
Class IActive
Body Armor® Stirrup Walker BPS4G
FDA UDI
Class IActive
DARCO® GentleStep™ Shoe GS105XB
FDA UDI
Class IActive
20'' Dlx Post-Op Knee Immob 462-0014-70
FDA UDI
Class IActive
DARCO® GentleStep™ Shoe GS060MB
FDA UDI
Class IActive
9'' Abdominal Binder 202-0050-55
FDA UDI
Class IActive
Health Design Classic Post Op Shoe HD-PO-CL4
FDA UDI
Class IActive
DARCO® AirTraveler™ Walker AT1
FDA UDI
Class IActive
DARCO® Body Armor® Cast Shoe BACS1
FDA UDI
Class IActive
Black Foam Wrist 451-4010-30L
FDA UDI
Class IActive
DARCO® GTS™ Great Toe Splint GTS2R
FDA UDI
Class IActive
DARCO® Body Armor® Toe Guard BATGS1
FDA UDI
Class IActive
Health Design Posi Wedge Post Op Shoe HD-PO-PW1
FDA UDI
Class IActive
Health Design Forefoot Reliever Post Op Shoe HD-PO-FR4
FDA UDI
Class IActive
DARCO® SlimLine™ cast boot SLQ4B
FDA UDI
Class IActive
Splint, Wrist, Lace-Up, Left, X-Large E59189
FDA UDI
Class IActive
Health Design Low Profile Cast Boot HD-CB-TP1
FDA UDI
Class IActive
DARCO® Web Ankle Brace WB3
FDA UDI
Class IActive
16'' Dlx Post-Op Knee Immob 462-0012-50
FDA UDI
Class IActive
Duo™ Pro Wound Care shoe DP2B
FDA UDI
Class IActive
Splint, Wrist, Lace-Up, Left, Large E59188
FDA UDI
Class IActive
DARCO® Body Armor® Walker BAW1
FDA UDI
Class IActive
Body Armor® Stirrup Walker BST0W
FDA UDI
Class IActive
POGO™ Pulsus PGP075N
FDA UDI
Class IActive
20'' Dlx Post-Op Knee Immob 462-0014-50
FDA UDI
Class IActive
Rigid-sole shoe RCW2B
FDA UDI
Class IActive
DARCO® DCS Plantar Fasciitis sleeve DCS-PF4-T
FDA UDI
Class IActive
Health Design Canvas Cast Boot HD-CB-CV2
FDA UDI
Class IActive
DARCO® Medical-surgical shoe MQW3B
FDA UDI
Class IActive
DARCO® MedSurg + Toe Cap C-MSTCM1
FDA UDI
Class IActive
DARCO® Body Armor® Walker liner BAWL2G
FDA UDI
Class IActive
DARCO® Monofilament Tester MFT
FDA UDI
Class IActive
Health Design Sof Touch Post Op Shoe HD-PO-ST4
FDA UDI
Class IActive
Splint, Wrist, Lace-Up, Left, Small E59186
FDA UDI
Class IActive
Knee Immobilizer, Super-Lite, Contoured Stay, 20" (xx-large) E59421
FDA UDI
Class IActive
DARCO® Body Armor® Walker II BAT0
FDA UDI
Class IActive
DARCO® Body Armor® Vario Ankle Brace BAV2R
FDA UDI
Class IActive
DARCO® GentleStep™ Shoe GS100XB
FDA UDI
Class IActive
DARCO® Night Splint NS3B
FDA UDI
Class IActive
DARCO® FXPro Walker Liner FXSL3
FDA UDI
Class IActive
DARCO® AirTraveler™ Walker Liner ATL4
FDA UDI
Class IActive
Knee Immobilizer, Super-Lite, Contoured Stay, 24" (x-large) E59425
FDA UDI
Class IActive
DARCO® Body Armor® Night Splint BADS
FDA UDI
Class IActive

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