Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615033

FEI Number

3005479189

Entity Name

FUJI DYNAMICS LIMITED

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 201, 40 Gao Yu South Road, Pin Shan, Tangxia Town, Dongguan Guangdong 523710, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FUJI DYNAMICS LIMITED (Owner Number: 9015622)

Owner / Operator Contact Address

Flat/RM A, 22/F, GRANDION PLAZA, NO. 932, CHEUNG SHA WAN ROAD, KOWLOON, HONG KONG, HK-NOTA 00000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K124016

PMA Number

N/A

All Registered Proprietary Names

INF4160 FD TENS 2010 FD TENS 2030 INF4160C IF 4K INF4160 PLUS INF 4160C FUJI TENS III MEDISANA DIGITAL TENS LL TENS PR0200 PR0100 EASY TENS PLUS OBI TENS SENATONE L-TENS FD TENS 2090 & FD TENS 2095 MEDISANA DIGITAL TENS EMPI PHOENIX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2007-08-24
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-08-04
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2000-08-07
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2011-02-10
GZQ	Instrument, Dowel Cutting	Neurology	Class 2	882.4275	2011-01-20
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-12-22
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-12-13
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-08-04
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2024-08-07
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2024-08-07
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-12-22
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2013-07-11
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2013-07-11
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2013-07-11

Official Correspondent

Kenneth Pang

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

FUJI DYNAMICS LIMITED

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
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03

Similar Registrations

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3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US
3010805941	BIO PROTECH YANTAI INC	Yantai Shandong, CN
3004558433	BIOWAVE CORPORATION	NORWALK, CT, US
3014315574	BRH MEDICAL LTD	Jerusalem, IL
3004049909	EASYMED INSTRUMENTS CO., LTD.	Daliang, Shunde, Foshan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615033. Last updated year: 2026. Please use registration number 9615033 when referencing this establishment in official correspondence.