Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027157200

FEI Number

3027157200

Entity Name

ACTLIFE TECHNOLOGY CO., LTD - THANH HOA BRANCH

City/State/Country

Trung Chinh Commune Thanh Hoa, VN

Establishment Address

Land lot 95, Bi Kieu Village,, Trung Chinh Commune Thanh Hoa None, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Actlife Technology Co., Ltd - Thanh Hoa Branch (Owner Number: 10087813)

Owner / Operator Contact Address

Land lot 95, Bi Kieu Village, Trung Chinh Commune, VN-21 None, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pack, hot or cold, reusable Orthosis, lumbar Hand Splints Thumb Stabilizer Ankles Orthosis, Abdominal Support, Arm Radiographic protective Glove Ice Bag Tape and bandage, Adhesive ORTHOSIS, LIMB BRACE Pack, Hot or Cold, Disposable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2023-04-12
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2026-03-02
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2023-04-12
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2023-04-12
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2026-03-02
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2023-04-12
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2023-12-19
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2023-04-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-03-02
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2023-04-12
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2026-03-02

Official Correspondent

Tung Nguyen

US Agent Details

John Lucas Business: HOLLIS CONSULTANCY, LLC Email: john.lucas.fda@gmail.com Phone: (770) 8963940

Related Public Records

Same Entity

Actlife Technology Co., Ltd - Thanh Hoa Branch

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
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

Similar Registrations

Registration Number	Establishment Name	Location
3037007193	SHANGHAI HUIZHOU INDUSTRIAL CO., LTD	Shanghai City District, CN
3031182683	NINGBO YAMAI INDUSTRY AND TRADE CO., LTD.	Yuyao Zhejiang, CN
3016711531	BRANCH IN PHU THO, THYGESEN TEXTILE VIETNAM COMPANY LIMITED	Yen Lap Commune Phu Tho, VN
3008384548	ACTIVE-ICE, INC.	Norman, OK, US
3002393819	MEDICAL SPECIALTIES OF CALIFORNIA LIMITED	Orpington Kent, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027157200. Last updated year: 2026. Please use registration number 3027157200 when referencing this establishment in official correspondence.