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VGH Solutions Inc: FDA-registered device maker in Markham Ontario, Canada, 14 510(k) clearances

Name: VGH Solutions Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

VGH Solutions Inc is registered with the FDA (registration 3007731000) in Markham Ontario, Canada. It lists 18 device types. The FDA files 14 510(k) clearances under its listings, the newest dated November 28, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007731000
Address: 145 Anderson Avenue, Markham Ontario, Canada, L6E1A4
Owner or operator: VGH Solutions Inc (10034033)
Roles: Exporter to the US
First device listed: October 29, 2010
Registered through: 2026
Brand names listed: Air Wave Cushion, Boomcare Infrared Ear & Forehead Thermometer, Circulation Promoter XP TENS, Circulation Sleeve for knee and calf, Back Belt, Therapy & Support Band, Knee Brace, Leg Rest, Back Pain Relief Shirt, Conductive Carbon Film Electrode, Conductive Silicon Rubber Electrode, DR-HO'S Adjustable Pillow, DR-HO'S Air Orthotics and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Exporter to the US	accessdata.fda.gov
Apparatus, Traction, Non-Powered	HST	1	Exporter to the US	accessdata.fda.gov
Component, Traction, Non-Invasive	KQZ	1	Exporter to the US	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Exporter to the US	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Exporter to the US	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Exporter to the US	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Exporter to the US	accessdata.fda.gov
Orthosis, Cervical	IQK	1	Exporter to the US	accessdata.fda.gov
Orthosis, Corrective Shoe	KNP	1	Exporter to the US	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Exporter to the US	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Exporter to the US	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Exporter to the US	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Exporter to the US	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Exporter to the US	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Exporter to the US	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Exporter to the US	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Exporter to the US	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Exporter to the US	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
November 28, 2025	K252658	Medical Diode Laser Systems (TR-B)	GEX	Substantially Equivalent	Baoding Te'Anzhou Electronic Technology Co., Ltd.	accessdata.fda.gov
May 16, 2024	K230711	Pain Therapy Device(Model: P.T.S-X)	NGX	Substantially Equivalent	Guangzhou Xinbo Electronic Co., Ltd.	accessdata.fda.gov
March 11, 2024	K231789	Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)	NGX	Substantially Equivalent	Guangzhou Xinbo Electronic Co., Ltd.	accessdata.fda.gov
August 9, 2023	K231167	Conductive Silicone Rubber Electrode	GXY	Substantially Equivalent	Guangzhou Xinbo Electronic Co., Ltd.	accessdata.fda.gov
August 9, 2023	K231164	Conductive carbon film electrode	GXY	Substantially Equivalent	Guangzhou Xinbo Electronic Co., Ltd.	accessdata.fda.gov
November 1, 2021	K212948	Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)	NGX	Substantially Equivalent	Guangzhou Xinbo Electronic Co., Ltd.	accessdata.fda.gov
August 16, 2021	K202636	Metallic Fabric Electrodes	GXY	Substantially Equivalent	Guangzhou Xinbo Electronic Co., Ltd.	accessdata.fda.gov
July 15, 2021	K202638	Pain Therapy Device	NGX	Substantially Equivalent	Guangzhou Xinbo Electronic Co., Ltd.	accessdata.fda.gov
May 13, 2020	K190118	Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)	GXY	Substantially Equivalent	Guangzhou Xinbo Electronic Co., Ltd.	accessdata.fda.gov
April 3, 2019	K182597	Infrared thermometer	FLL	Substantially Equivalent	Shenzhen Pango Electronic Co., Ltd.	accessdata.fda.gov
April 19, 2018	K172887	XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)	GXY	Substantially Equivalent	Guangzhou Xinbo Electronic Co., Ltd.	accessdata.fda.gov
September 19, 2017	K163611	Pain Therapy Device	NUH	Substantially Equivalent	Guangzhou Xinbo Electronic Co., Ltd.	accessdata.fda.gov
May 10, 2013	K121719	SM TENS & PMS	NGX	Substantially Equivalent	Hong Qiangxing (Shenzhen) Electronics Limited	accessdata.fda.gov
June 23, 2009	K090198	JIAJIAN SELF-ADHESIVE ELECTRODE	GXY	Substantially Equivalent	Wuxi Jiajian Medical Instrument Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 28, 2025. 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.