Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010402752

FEI Number

3010402752

Entity Name

HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

2F, Yongcheng Blvd, Xicheng Industrial Zone, Xixiang Street, Bao'an District, Shenzhen Guangdong 518126, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Hong Qiangxing (Shen Zhen) Electronics Limited (Owner Number: 10044280)

Owner / Operator Contact Address

2F, Yongcheng Blvd, Xicheng Industrial Zone, Xixiang Street, Bao'an District, Shenzhen, CN-GD 518126, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133108

PMA Number

N/A

All Registered Proprietary Names

ManaFlexx 2 (model: MF002-RX, MF002-OTC) Manual massager; Massage slippers SM Electrodes Massage gloves, Massage socks, Massage belts, Massage slippers Proactive Elle TENS replacement electrodes (715-736) Foot mat VPOD Electrodes Face Evolution-EMS & LED Facial Toning Therapy Waist Belt SM TENS & PMS AIO I-QC SM9128M Stimulator, Nerve, Transcutaneous, Over-The-Counter TENS 7000 Rechargeable Pixie Pulse Epulse Pro 900 SM9128 SM9128 NEOCARBON PainX® TENS PRO, SM9069C TENS & PMS (Model: SM9126, SM9910) DrBash TENS&EMS TAKOO PainX® TENS PRO, SM9069C Criterion® TENS 7000 Rechargeable TENS&EMS Units (SM9109A, SM9109B) Wireless Muscle Stimulator (SM9109A, SM9109B) SM9055A CESLIFF; SM9055B Belifu; SM9055C Belifu; SM9055 Neocarbon TENS & PMS (Model SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) Skincare rejuvenation, SM9003, SM9005 SonicLift Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) VPod, VPod Deluxe, VPod single NeuroMD SM9187N (RL-019-Y) OrthoTape Tens Unit Machine Therapy, SM9187S Upcore Mini PAIN BRAIN MD Crampology Relief Pink Nooro Whole Body Massager 1; Nooro Foot Massager 1 Proactive Elle TENS device (715-432) TheraSTIM RTM ManaFlexX2 Wireless 1600 Monthlee, SM9187 SM9023 Wireless TENS & EMS (Model SM9110, SM9113, SM9116) Foot Pain Relief CoreeLab ESPF Massager YUNJIAODIDAN Foot Massager 1 TENS Device Epulse Ultra 1420 Pain Therapy Device (SM9055, SM9075, SM9910, SM9067, SM9587W) SM9075 NEOCARBON Nooro Body & Foot Stimulator (SM9141, SM9142) Electrode cable Fit Belt Abs NRG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-09-01
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2024-09-01
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-09-01
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2024-09-01
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2024-09-01
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2018-03-27
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2013-05-20
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-03-27
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2019-08-13
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2019-08-13
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2019-08-13
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2014-12-15
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2013-05-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2013-05-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2022-04-07
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2022-04-07
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2023-11-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-07-28
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2023-07-28
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-11-07
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-11-07
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2022-05-04
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2022-05-04
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2020-09-22
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2020-02-19
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-02-19
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2024-08-08
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2024-08-08
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-08-08
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-08-08
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-04-05
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-04-15
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2024-04-15
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-04-15
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2024-04-15
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2024-04-15
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-01-23
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2025-01-23
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2025-01-23
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-01-23
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2025-01-23
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2013-05-20
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2018-03-27
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2019-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (920) 6019045

Related Public Records

Same Entity

Hong Qiangxing (Shen Zhen) Electronics 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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3029924973	SHENZHEN SINREL TECH LTD	Shenzhen Guangdong, CN
3003255790	WITKO INCORPORATED	Wolcott, IN, US
3038295706	JUST KEEP HEALTHY CO., LTD.	Samkkei Munichay District Kampong Speu, KH
3011562129	MIRAE MEDI&TECH CO., LTD.	Cheonan-si Chungnam, KR
3005170249	Shenzhen Dongdixin Technology Co., Ltd.	SHENZHEN Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010402752. Last updated year: 2026. Please use registration number 3010402752 when referencing this establishment in official correspondence.