Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029923680

FEI Number

3029923680

Entity Name

PT NEWLIFE HEALTHCARE INTERNATIONAL

City/State/Country

Kota Administrasi Jakarta Utara, ID

Establishment Address

Jl. Sumatera Block D.19, Cakung Nusantara Bonded Zone , Desa/Kelurahan Sukapura, Kec. Cilincing,, Kota Administrasi Jakarta Utara 14140, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PT NEWLIFE HEALTHCARE INTERNATIONAL (Owner Number: 10089022)

Owner / Operator Contact Address

Jl. Sumatera Block D.19, Cakung Nusantara Bonded Zone , Desa/Kelurahan Sukapura, Kec. Cilincing,, Kota Adm. Jakarta Utara, Provinsi DKI Jakarta, 14140, Kota Administrasi Jakarta Utara, ID-NOTA 14140, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Heelmedix Boot Basic Foam Wedges INFUSOR,PRESSURE,FOR I.V. BAGS Disposable BP Cuffs Medline Hemo-Force DVT Compression Sleeve Bubble Cushion Gait belt Homecare Foam Mattress

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	2025-02-24
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2024-11-01
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2024-11-01
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2025-03-18
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-10-30
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2024-06-18
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2026-04-01
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2024-06-21

Official Correspondent

Mark Zhu

US Agent Details

Paul Li Email: lisa@zxwy-md.com Phone: (312) 9856751

Related Public Records

Same Entity

PT NEWLIFE HEALTHCARE INTERNATIONAL

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
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13
K972301	Rudolf Riester GmbH & Co. KG	BIG BEN SQUARE, BIG BEN ROUND	1997-09-17
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

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3043364423	SAMGEN MEDICAL LLC	Cherry Hill, NJ, US
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 3029923680. Last updated year: 2026. Please use registration number 3029923680 when referencing this establishment in official correspondence.