Data / Medical devices / China / Yiwu Inwell Craft&gift Co.,ltd

Yiwu Inwell Craft&gift Co.,ltd: FDA-registered device maker in Jin Hua Zhejiang, China, 5 510(k) clearances

Name: Yiwu Inwell Craft&gift Co.,ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Yiwu Inwell Craft&gift Co.,ltd is registered with the FDA (registration 3031980484) in Jin Hua Zhejiang, China. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 8, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Yiwu Inwell Craft&gift Co.,ltd

FDA registration number: 3031980484
Address: No118.Yongjun Road,North Beiyuan District, Yiwu, Jin Hua Zhejiang, China, 322000
Owner or operator: yiwu inwell craft&gift co.,ltd (10095926)
Roles: Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
First device listed: May 24, 2026
Registered through: 2026
Brand names listed: 6-in-1 Rechargeable Scalp Massager Brush, Complete Joint Support Kit (Knee Brace with Dial Adjustment One Size Wrist Wrap), MT Cap, OCD MT Cap, Treatment Pack

Devices it lists

Device	Product code	Class	Role	Source
Joint, Knee, External Brace	ITQ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Exporter to the US	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	QCI	2	Manufacturer	accessdata.fda.gov
Transcranial Magnetic Stimulator	OBP	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
June 8, 2023	K231350	OCD MT Cap (85-00397-000)	QCI	Substantially Equivalent	Neuronetics	accessdata.fda.gov
May 6, 2022	K212289	NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar	QCI	Substantially Equivalent	Neuronetics, Inc.	accessdata.fda.gov
December 10, 2021	K213543	NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health	OBP	Substantially Equivalent	Neuronetics, Inc.	accessdata.fda.gov
July 26, 2019	K190685	Hair Growth System	OAP	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov
September 11, 2016	K161519	NeuroStar TMS Therapy System	OBP	Substantially Equivalent	Neuronetics, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 8, 2023. 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.