Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005282622

FEI Number

3005282622

Entity Name

ALLARD USA INC.

City/State/Country

ROCKAWAY, NJ, US

Establishment Address

300 Forge Way Ste 3, ROCKAWAY, NJ 07866, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

Allard Support for Better Life AB (Owner Number: 8030901)

Owner / Operator Contact Address

38 KARBINGATAN, --, HELSINGBORG, SE-NOTA SE-254 67, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FORGE CSUS M2 VISSION Vission NAVY Aosuo prosthetic foot shell VISSION FORGE CSUS M2 Vission S.O.T AND COMPONENTS SELECTION WRIST SPLINTS LSO Xtra LSO+ FORGE CSUS VISSION M2 MultiMotion BINKY Kid-Dee-Lite FORGE CSUS M2 VISSION Meracus One VISSION CSUS M2 FORGE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2010-07-30
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2005-07-28
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2024-10-10
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2010-07-30
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2005-07-28
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2010-07-30
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2005-07-28
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2010-07-30
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2024-06-25
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2010-07-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Allard Support for Better Life AB

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8030901	CAMP SCANDINAVIA AB	HELSINGBORG Skane, SE

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3040314203	LU MARK USA ENTERPRISES INC	Brea, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005282622. Last updated year: 2026. Please use registration number 3005282622 when referencing this establishment in official correspondence.