Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1122845

FEI Number

1000123428

Entity Name

DARCO INTERNATIONAL, INC.

City/State/Country

HUNTINGTON, WV, US

Establishment Address

810 Memorial Blvd W, HUNTINGTON, WV 25701, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

DARCO INTERNATIONAL, INC. (Owner Number: 9001626)

Owner / Operator Contact Address

810 MEMORIAL BLVD., --, Huntington, WV 25701, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BODY ARMOR WALKER BODY ARMOR PRO TERM ACTIVE ANKLE DORSAL NIGHT SPLINT BODY ARMOR WALKER II BODY ARMOR NIGHT SPLINT FX PRO ANTERIOR CARBON FIBER AFO COMPONENT KIT ANT AFO TOE ALIGNMENT SPLINT BODY ARMOR STIRRUP WALKER GREAT TOE SPLINT Body Armor PFA Walker ANT AFO TABS SACRO LUMBAR SUPPORT DARCO SACRO LUMBAR SUPPORT ANKLE EXTERNAL BRACE DARCO ANKLE BRACE DARCOGEL ANKLE BRACE BODY ARMOR SPORT BODY ARMOR STIRRUP WEB ANKLE BRACE BODY ARMOR VARIO Pneumatic Night Splint Body Armor Stirrup Walker Pneumatic Air Traveler Walker Body Armor PFA Walker Liner Body Armor PFA Walker WALKER LINER MULTI PHASE PADS PEG ASSIST ACTIMOVE LINER BODY ARMOR HEEL RELIEVER SPENCO BOOT LINER BODY ARMOR TOE GUARD MEDICAL SURGICAL SHOE Body Armor Cast Shoe Vinyl Closed Toe Cast Boot Slimline Cast Boot Polycast Cast Boot Low Profile Cast Shoe Canvas/Open Toe Cast Shoe Standard Open Toe Cast Boot Body Armor Tape Darco Abdominal Binder BUNGEE WRIST DARCO WRIST BRACE AllRound Shoe Gentle Step Wound Care Shoe Duo Shoe Heelwedge Pogo Pulsus Ultra Off Loading Shoe Strapless Shoe All Purpose Boot Softie Shoe Medical Surgical Shoe Orthowedge Original Medical Surgical Shoe Duo Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2008-05-27
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2006-07-17
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2006-07-17
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2007-03-19
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2006-07-17
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2006-07-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2009-12-30
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2006-07-17
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2006-07-17
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2006-09-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DARCO INTERNATIONAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006026111	DARCO (Europe) GmbH	RAISTING Bavaria, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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3029961128	GERO3D LTD	Tel Aviv-Yafo Central, IL
3043047582	OY PRIMO FINLAND AB	Vaasa Pohjanmaa, FI
3018759542	DIMENSION ORTHO Inc.	Philadelphia, PA, US
3009605026	JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.	Yancheng Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1122845. Last updated year: 2026. Please use registration number 1122845 when referencing this establishment in official correspondence.