Question 1

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

Accepted Answer

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.

Question 2

Where is DARCO International, Inc. based?

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Health Design Classic Post Op Shoe	HD-PO-CL2	FDA UDI	Class I	Active
Body Armor® Stirrup Walker	BPT3G	FDA UDI	Class I	Active
DARCO® GentleStep™ Shoe	GS105MB	FDA UDI	Class I	Active
Health Design Canvas Cast Boot	HD-CB-CV5	FDA UDI	Class I	Active
POGO™ Pulsus	PGP085B	FDA UDI	Class I	Active
DARCO® Body Armor® Night Splint	BADS-S	FDA UDI	Class I	Active
DARCO® FX Pro™ Walker	FX3	FDA UDI	Class I	Active
Body Armor® Stirrup Walker	BPT4G	FDA UDI	Class I	Active
DARCO® GentleStep™ Shoe	GS100MB	FDA UDI	Class I	Active
DARCO® Medical-surgical shoe	MQM3B	FDA UDI	Class I	Active
DARCO® GentleStep™ Shoe	GS115XB	FDA UDI	Class I	Active
DARCO® GTS™ Great Toe Splint	GTS2L	FDA UDI	Class I	Active
Health Design Vinyl Cast Boot	HD-CB-VN5	FDA UDI	Class I	Active
Body Armor® Stirrup Walker	BPT1G	FDA UDI	Class I	Active
DARCO® Peg-Assist™ Off-loading Insole	PTQM3	FDA UDI	Class I	Active
DARCO® MedSurg + Toe Cap	C-MSTCM2	FDA UDI	Class I	Active
Cast boot, canvas	CBO4	FDA UDI	Class I	Active
DARCO® DCS Plantar Fasciitis sleeve	DCS-PF1-T	FDA UDI	Class I	Active
DARCO® GentleStep™ Shoe	GS080MB	FDA UDI	Class I	Active
Health Design EZY Close Post Op Shoe	HD-PO-EZ2	FDA UDI	Class I	Active
Darco Force Titanium Compression Screw	K062103	FDA 510(k)	Class II	Active
Darco Locking Bone Plate System	K061808	FDA 510(k)	Class II	Active

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