Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034694939

FEI Number

3034694939

Entity Name

ABLETECH ORTHOPEDICS CORPORATION

City/State/Country

New Taipei City Taiwan, CN

Establishment Address

15F-3 No.1 Baosheng Rd., Yonghe Dist., New Taipei City Taiwan 234635, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Abletech Orthopedics Corporation (Owner Number: 10092117)

Owner / Operator Contact Address

15F-3 No.1 Baosheng Rd., Yonghe Dist., New Taipei City, CN-TW 234635, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stirrup, External Brace Component Orthosis, Corrective Shoe Joint, Ankle, External Brace Sling, Arm, Overhead Supported Band or Belt Pelvic Support (Proprietary Name) Orthosis Cervical Thoracic Rigid Splint, Hand, And Components Joint, Hip, External Brace Pack, Hot or Cold Disposable Orthosis Lumbo-Sacral Cushion Flotation Joint, Knee, External Brace Splint, Extremity, Inrlatable, External Support, Arm Orthosis, Limb Brace Apparatus, Traction, non powered

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	2024-12-05
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2024-12-05
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2024-12-05
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2024-12-05
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2024-12-05
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2024-12-05
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-12-05
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2024-12-05
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-12-05
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2024-12-05
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2024-12-05
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2024-12-05
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2024-12-05
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2024-12-05
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-12-05
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2024-12-05

Official Correspondent

Ramon Tseng

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Abletech Orthopedics Corporation

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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3014658541	SECURED ORTHO MANUFACTURING OF AMERICA, LLC	Deer Park, NY, US
1640425	BORDER OPPORTUNITY SAVER SYSTEMS, INC.	Del Rio, TX, US
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 3034694939. Last updated year: 2026. Please use registration number 3034694939 when referencing this establishment in official correspondence.