Is this your brand? Sign in to claim ownership.
Sign in to claim this brandDARCO 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
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000123428
- DUNS Number
- —
Catalogue (572)
Page 4 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DARCO® GentleStep™ Shoe | GS145MB | FDA UDI | Class I | Active |
| POGO™ Pulsus | PGP115G | FDA UDI | Class I | Active |
| Health Design Classic Post Op Shoe | HD-PO-CL6 | FDA UDI | Class I | Active |
| Body Armor® Stirrup Walker | BPS0W | FDA UDI | Class I | Active |
| DARCO® PegAssist® Insole | PAS-STL3 | FDA UDI | Class I | Active |
| POGO™ Pulsus | PGP105B | FDA UDI | Class I | Active |
| Body Armor® Stirrup Walker | BST2G | FDA UDI | Class I | Active |
| DARCO® GentleStep™ Shoe | GS135WB | FDA UDI | Class I | Active |
| Rigid-sole shoe | RCM4B | FDA UDI | Class I | Active |
| DARCO® Body Armor® Cast Shoe | BACS2 | FDA UDI | Class I | Active |
| POGO™ Pulsus | PGP120B | FDA UDI | Class I | Active |
| DARCO® Peg-Assist™ Off-loading Insole | PQ1 | FDA UDI | Class I | Active |
| DARCO® GentleStep™ Shoe | GS070WB | FDA UDI | Class I | Active |
| Health Design Canvas Cast Boot | HD-CB-CV1 | FDA UDI | Class I | Active |
| Knee Immobilizer, Tri-Panel, 24" | E62655 | FDA UDI | Class I | Active |
| DARCO® Peg-Assist™ Off-loading Insole | PQ3 | FDA UDI | Class I | Active |
| DARCO® MedSurg + Toe Cap | C-MSTCM4 | FDA UDI | Class I | Active |
| DARCO® HeelWedge™ shoe | HQ1B | FDA UDI | Class I | Active |
| POGO™ Pulsus | PGP110N | FDA UDI | Class I | Active |
| DARCO® OrthoWedge™ healing shoe | OQ0B | FDA UDI | Class I | Active |
| DARCO® Medical-surgical shoe | MQM2B | FDA UDI | Class I | Active |
| POGO™ Pulsus | PGP100N | FDA UDI | Class I | Active |
| DARCO® Softie™ shoe | STM4B | FDA UDI | Class I | Active |
| DARCO® Body Armor® Vario Ankle Brace | BAV3L | FDA UDI | Class I | Active |
| 16'' Dlx Post-Op Knee Immob | 462-0012-30 | FDA UDI | Class I | Active |
| Duo™ Pro Wound Care shoe | DP0B | FDA UDI | Class I | Active |
| DARCO® Body Armor® Walker liner | BAWSL2G | FDA UDI | Class I | Active |
| DARCO® DCS Plantar Fasciitis sleeve | DCS-PF2 | FDA UDI | Class I | Active |
| DARCO® GentleStep™ Shoe | GS135XB | FDA UDI | Class I | Active |
| POGO™ Pulsus | PGP095G | FDA UDI | Class I | Active |
| DARCO® APB™ All Purpose Boot | APQ1B | FDA UDI | Class I | Active |
| DARCO® MedSurg + Toe Cap | C-MSTCW3 | FDA UDI | Class I | Active |
| DARCO® Night Splint | NS1B | FDA UDI | Class I | Active |
| 20'' Dlx Post-Op Knee Immob | 462-0014-30 | FDA UDI | Class I | Active |
| DARCO® Duo™ Medical-surgical shoe | DS3B | FDA UDI | Class I | Active |
| Health Design Polycast Cast Boot | HD-CB-PC1 | FDA UDI | Class I | Active |
| Health Design Polycast Cast Boot | HD-CB-PC2 | FDA UDI | Class I | Active |
| Health Design EZY Close Post Op Shoe | HD-PO-EZ1 | FDA UDI | Class I | Active |
| DARCO® FXPro Walker Liner | FXL4 | FDA UDI | Class I | Active |
| DARCO® Body Armor® Sport Ankle Brace | BAS2R | FDA UDI | Class I | Active |
| DARCO® PegAssist™ Insole | PAS-STL4 | FDA UDI | Class I | Active |
| POGO™ Pulsus | PGP105G | FDA UDI | Class I | Active |
| DARCO® GentleStep™ Shoe | GS080WB | FDA UDI | Class I | Active |
| DARCO® Body Armor® Sport Ankle Brace | BAS3R | FDA UDI | Class I | Active |
| DARCO® GentleStep™ Shoe | GS070MB | FDA UDI | Class I | Active |
| Cast boot, canvas | CBO0 | FDA UDI | Class I | Active |
| Cast boot, canvas | CBO3 | FDA UDI | Class I | Active |
| DARCO® Body Armor® Walker | BAWS1 | FDA UDI | Class I | Active |
| Splint, Wrist, Lace-Up, Left, X-Small | E59185 | FDA UDI | Class I | Active |
| DARCO® SlimLine™ cast boot | SLO1NP | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.