Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014658541

FEI Number

3014658541

Entity Name

SECURED ORTHO MANUFACTURING OF AMERICA, LLC

City/State/Country

Deer Park, NY, US

Establishment Address

28 West Jefryn Boulevard, Suite C, Deer Park, NY 11729, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Secured Ortho Manufacturing of America, LLC (Owner Number: 10057821)

Owner / Operator Contact Address

28 West Jefryn Boulevard, Suite C, Deer Park, NY 11729, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ankle stirrup commode crutch accessories camwalker arm sling mechanical chair arm support cane wrist splint hip brace cast shoe cervical collar back brace knee brace folding walker prosthetic cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITC	Stirrup, External Brace Component	Physical Medicine	Class 1	890.3410	2018-05-30
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2018-05-30
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2018-05-30
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2018-05-30
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2018-05-30
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2018-05-30
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-05-30
IPS	Cane	Physical Medicine	Class 1	890.3075	2018-05-30
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2018-05-30
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2018-05-30
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2018-05-30
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2018-05-30
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2018-05-30
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2018-05-30
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2025-09-15
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2018-05-30
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2018-05-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Secured Ortho Manufacturing of America, LLC

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

Similar Registrations

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3016515429	SECURE MANUFACTURING (THAILAND) CO., LTD.	Bangkok Krung Thep Maha Nakhon, TH
1640425	BORDER OPPORTUNITY SAVER SYSTEMS, INC.	Del Rio, TX, US
3034694939	ABLETECH ORTHOPEDICS CORPORATION	New Taipei City Taiwan, CN
1051118	RESTORATIVE CARE OF AMERICA, INC.	Saint Petersburg, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014658541. Last updated year: 2026. Please use registration number 3014658541 when referencing this establishment in official correspondence.