Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014314933

FEI Number

3014314933

Entity Name

SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

202,2/F, Building 27, Dafa Industrial Park, Longxi Community, Longgang Street, Longgang District, Shenzhen Guangdong 518116, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Roundwhale Technology Co. Ltd. (Owner Number: 10057039)

Owner / Operator Contact Address

202,2/F, Building 27, Dafa Industrial Park, Longxi Community, Longgang Street, Longgang District, Shenzhen, CN-GD 518116, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231440

PMA Number

N/A

All Registered Proprietary Names

ISTIM M2 TME-UTA BRVE2 ZZACOMBOBDPT1 R-C101J, R-C3,R-C4A,R-C4B,R-C4C,R-C4D,CNT-TENS-100,Magic, M100A, M101A, R-C1-K01,M102A TENS 3N1, TENS 3N1R, TENS 12MT, TENS 3MT, TENS 7500, R-C5 Combo Electrotherapy Device (Magic), Combo Electrotherapy Device (R-C101J),AE177 R-C4D-RW1 ZZACOMBOBDPT2 RHB2026GRY Combo Electrotherapy Device (M101A-UK1) ZZACOMBO Electrode Cable Self-Adhesive Electrode Self-Adhesive Electrode with lead wire Self-Adhesive Electrode with Snap/Magnetic connector MASSAGER: R-C1,R-T1,R-E1,R-C3,R-C4A,R-C4B,R-C4C,R-C4D Combo Electrotherapy Device(Model:R-C10IW,R-C101A,R-C101B,R-C101E,R-C101H,R-C101D,R-C101G)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2019-12-09
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2019-12-09
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2019-12-09
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2019-12-09
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2018-02-13
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2023-08-09
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2019-07-11
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2023-11-06
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2023-11-06
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2023-11-06

Official Correspondent

Kevin Zhang

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Shenzhen Roundwhale Technology Co. Ltd.

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
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
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

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3038295706	JUST KEEP HEALTHY CO., LTD.	Samkkei Munichay District Kampong Speu, KH
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 3014314933. Last updated year: 2026. Please use registration number 3014314933 when referencing this establishment in official correspondence.