Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016515429

FEI Number

3016515429

Entity Name

SECURE MANUFACTURING (THAILAND) CO., LTD.

City/State/Country

Bangkok Krung Thep Maha Nakhon, TH

Establishment Address

114 Soi Tubyao 1, Sangkhapracha Rd., Tubyao, Ladkrabang, Bangkok Krung Thep Maha Nakhon 10520, TH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Secure Manufacturing (Thailand) Co., Ltd. (Owner Number: 10077048)

Owner / Operator Contact Address

114 Soi Tubyao 1, Sangkhapracha Rd., Tubyao, Ladkrabang, Bangkok, TH-10 10520, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Forte Secure Wear

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	2021-11-24
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2021-11-24
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-09-12
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2021-11-24
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2026-02-11
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2021-11-24
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-08-10
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2021-11-24
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2025-09-15
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-09-13
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2023-01-25
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2021-11-24

Official Correspondent

Michael McDermott

US Agent Details

Vincent Benenati Business: Span Link International, LLC Email: vincent.benenati@slibracing.com Phone: (516) 3433372

Related Public Records

Same Entity

Secure Manufacturing (Thailand) Co., 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3006979871	TRULIFE, LTD.	S. Yorkshire Sheffield, GB
3014658541	SECURED ORTHO MANUFACTURING OF AMERICA, LLC	Deer Park, NY, US
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 3016515429. Last updated year: 2026. Please use registration number 3016515429 when referencing this establishment in official correspondence.