Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006619688

FEI Number

3006619688

Entity Name

UNITED SURGICAL, LTD.

City/State/Country

P.U. KADDA, GAZIPUR, BD

Establishment Address

93, ISLAMPUR, P.U. KADDA, GAZIPUR GA 21 PUR, BD

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

UNITED SURGICAL, LTD. (Owner Number: 9095103)

Owner / Operator Contact Address

93, ISLAMPUR, --, P.U. KADDA, GAZIPUR, BD-NOTA GA 21 PUR, BD

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ankle Brace Wrist/Hand Brace Commode Attachment Protective Restraint Sling Arm Sling Knee Brace Transfer Aid Limb Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2006-11-29
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2006-11-29
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2017-05-04
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2021-06-14
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2025-07-03
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2006-11-29
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2006-11-29
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2020-08-10
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2006-11-29

Official Correspondent

No official correspondent registered.

US Agent Details

Andy Opliger Business: United Ortho Email: andyo@united-ortho.com Phone: (260) 4456202

Related Public Records

Same Entity

UNITED SURGICAL, LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

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3010646683	HARNOSANDS PLASTINDUSTRI AB	Harnosand Vasternorrland, SE
3012164853	Wilsons nc Enterprice LLC	Washington, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006619688. Last updated year: 2026. Please use registration number 3006619688 when referencing this establishment in official correspondence.