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Shenzhen Hengbosi Industrial Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 13 510(k) clearances

Name: Shenzhen Hengbosi Industrial Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenzhen Hengbosi Industrial Co., Ltd. is registered with the FDA (registration 3030539046) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 13 510(k) clearances under its listings, the newest dated February 27, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3030539046
Address: 1035 Chuangke Building, No.72-6 Huanguan South Road, Xintian Community, Guanhu Street, Longhua District, Shenzhen Guangdong, China, 518000
Owner or operator: Shenzhen Hengbosi Industrial Co., Ltd. (10089895)
Roles: Manufacturer, Repackager or relabeler
First device listed: January 19, 2024
Registered through: 2026
Brand names listed: ABS Stimulator (Model: AST-301), EMS Foot Massager with Heat & Red Light Therapy, EMS Toning Shorts, Electronic Muscle Stimulator (Brand: MarCoolTrip MZ, Model: AST-300N, AST-301), Hand Massager, Muscle Stimulator for Wrist, Migraine Relief Device, Muscle Stimulator Fitness Training for Abdomen/Arm/Leg, Muscle Stimulator for Abdomen/Arm/Leg (Model: AST-303) and more

Devices it lists

Device	Product code	Class	Role	Source
Pad, Heating, Powered	IRT	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 27, 2024	K222400	Coresculpt & Magsculpt	NGX	Substantially Equivalent	K1Med Co., Ltd.	accessdata.fda.gov
January 8, 2024	K233035	Electronic Muscle Stimulator (Model MP01)	NGX	Substantially Equivalent	Shenzhen Hengbosi Industrial Co., Ltd.	accessdata.fda.gov
June 16, 2023	K231136	Fitness Belt (Model: KLT-07)	NGX	Substantially Equivalent	Shenzhen Kelutongda Industrial Co., Ltd.	accessdata.fda.gov
June 11, 2022	K221384	Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2	NUH	Substantially Equivalent	Hivox Biotek, Inc.	accessdata.fda.gov
February 26, 2019	K183454	Tyece OTC EMS System	NGX	Substantially Equivalent	Tyece , Ltd.	accessdata.fda.gov
December 20, 2016	K162630	CP Relief Wand-OTC	NUH	Substantially Equivalent	Mid-America Medical Innovations, LLC	accessdata.fda.gov
September 2, 2011	K102933	GEM-TONE BODY TRAINING SYSTEM	NGX	Substantially Equivalent	Gemore Technology Co, Ltd.	accessdata.fda.gov
February 18, 2011	K102295	X2ABS DUAL CHANNEL FITNESS BELT	NGX	Substantially Equivalent	Leto Enterprises Incorporation	accessdata.fda.gov
May 7, 2010	K092476	SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M	NGX	Substantially Equivalent	Sport-Elec	accessdata.fda.gov
November 5, 2008	K081026	BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5	NGX	Substantially Equivalent	Sport-Elec S.A.	accessdata.fda.gov
June 17, 2003	K023726	TENS PRO 900	GZJ	Substantially Equivalent	Acumed Medical Supplies , Ltd.	accessdata.fda.gov
March 17, 1997	K970155	NEURO-TRAIN II (2)	IPF	Substantially Equivalent	Sterne Equipment Co., Ltd.	accessdata.fda.gov
December 28, 1994	K940301	COMPEX 2	IPF	Substantially Equivalent for Some Indications	Biodex Medical Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.