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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 9 of 12
DeviceModel / ReferenceRegistriesClassStatus
DARCO® Web™ Ankle brace WB3
FDA UDI
Class IActive
20'' Dlx 3-Panel Knee Immob 462-0026-10
FDA UDI
Class IActive
DARCO® MedSurg + Toe Cap C-MSTCM3
FDA UDI
Class IActive
Body Armor® Stirrup Walker BPS1G
FDA UDI
Class IActive
DARCO® Body Armor® Embrace EB3B-R
FDA UDI
Class IActive
Health Design Low Profile Cast Boot HD-CB-TP2
FDA UDI
Class IActive
Body Armor® Stirrup Walker BPS3G
FDA UDI
Class IActive
DARCO® APB™ All Purpose Boot APQ4B
FDA UDI
Class IActive
POGO™ Pulsus PGP105N
FDA UDI
Class IActive
Knee Immobilizer, Tri-Panel, 20" E62653
FDA UDI
Class IActive
DARCO® SlimLine™ cast boot SLQ0B
FDA UDI
Class IActive
DARCO® Bungee wrist brace 9BW3L
FDA UDI
Class IActive
DARCO® FXPro Walker Liner FXL0
FDA UDI
Class IActive
POGO™ Pulsus PGP100G
FDA UDI
Class IActive
DARCO® Night Splint NW2B
FDA UDI
Class IActive
Darco® A.p.b.™ APB0B
FDA UDI
Class IActive
Body Armor® Stirrup Walker BST3G
FDA UDI
Class IActive
Body Armor® Stirrup Walker BST1G
FDA UDI
Class IActive
Health Design Posi Wedge Post Op Shoe HD-PO-PW4
FDA UDI
Class IActive
DARCO® DCS Plantar Fasciitis sleeve DCS-PF2-B
FDA UDI
Class IActive
Splint, Wrist, Lace-Up, Left, Medium E59187
FDA UDI
Class IActive
DARCO® PegAssist™ Insole PAS-W1
FDA UDI
Class IActive
Health Design Ankle Leg Walker HD-LWS-MM2
FDA UDI
Class IActive
DARCO® AirTraveler™ Walker ATS0
FDA UDI
Class IActive
DARCO® Body Armor® Walker liner BAWL3G
FDA UDI
Class IActive
Knee Immobilizer S/A, Super-Lite, 12" E62644
FDA UDI
Class IActive
Health Design Sof Touch Post Op Shoe HD-PO-ST2
FDA UDI
Class IActive
Splint, Wrist, Lace-Up, Right, X-Small E59180
FDA UDI
Class IActive
Rigid-sole shoe RCW1B
FDA UDI
Class IActive
Darco® A.p.b.™ APB2B
FDA UDI
Class IActive
DARCO® GTS™ Great Toe Splint GTS1L
FDA UDI
Class IActive
DARCO® GentleStep™ Shoe GS160WB
FDA UDI
Class IActive
DARCO® GentleStep™ Shoe GS145XB
FDA UDI
Class IActive
Health Design Tall Leg Walker HD-LWL-MM2
FDA UDI
Class IActive
DARCO® Cast Boot Pediatric CB-PED1
FDA UDI
Class IActive
DARCO® Peg-Assist™ Off-loading Insole PTQM2
FDA UDI
Class IActive
DARCO® Body Armor® Elastic Tape (red) BAET-R
FDA UDI
Class IActive
Knee Immobilizer, Super-Lite, Contoured Stay, 16" (large) E59416
FDA UDI
Class IActive
Health Design Classic Post Op Shoe HD-PO-CL5
FDA UDI
Class IActive
Body Armor® Stirrup Walker BPT0W
FDA UDI
Class IActive
DARCO® AirTraveler™ Walker Liner ATSL0
FDA UDI
Class IActive
20'' Dlx 3-Panel Knee Immob 462-0028-10
FDA UDI
Class IActive
DARCO® FXPro Walker Liner FXSL0
FDA UDI
Class IActive
POGO™ Pulsus PGP120G
FDA UDI
Class IActive
DARCO® Foot Filament FF
FDA UDI
Class IActive
DARCO® AirTraveler™ Walker ATS1
FDA UDI
Class IActive
DARCO® GentleStep™ Shoe GS075XB
FDA UDI
Class IActive
DARCO® GentleStep™ Shoe GS090WB
FDA UDI
Class IActive
Health Design Ankle Leg Walker HD-LWS-MM4
FDA UDI
Class IActive
DARCO® GentleStep™ Shoe GS055WB
FDA UDI
Class IActive

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