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Hebei Tuosite Technology Co.,ltd: FDA-registered device maker in Shijiazhuang Hebei, China, 2 510(k) clearances

Name: Hebei Tuosite Technology Co.,ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hebei Tuosite Technology Co.,ltd is registered with the FDA (registration 3043149902) in Shijiazhuang Hebei, China. It lists 14 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 17, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3043149902
Address: Room 2911, Tower A, MixC Mall, Qiaoxi District, Shijiazhuang Hebei, China, 050000
Owner or operator: Hebei Tuosite Technology Co.,Ltd (10094850)
Roles: Manufacturer
First device listed: December 29, 2025
Registered through: 2026
Brand names listed: AN-T001,AS8008,AS9002, V39,V687,V9,V10, Air pressure suit:BR604,BR610,BR611,BR618,BR615,BR619PRO, Body analyzer machine:GS6.5C,GS7,GS6.7, CTM49,CTM27,CTM685S,XM278JK-CS01,JK-CS02,JK-CS03, Dermatological Diode Laser Systems, Diode Laser Hair Removal System:TSLA01,TSLA02,TSLA03,TSLA04, ELECTRONIC MUSCLE STIMULATOR, EMS face:EMS11,EMS12,EMS13,EMS14,EMS15 and more

Devices it lists

Device	Product code	Class	Role	Source
Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase	DLI	1	Manufacturer	accessdata.fda.gov
Device, Pressure Applying	KNM	1	Manufacturer	accessdata.fda.gov
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	PZL	2	Manufacturer	accessdata.fda.gov
Gas, Laser Generating	NXF	1	Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Manufacturer	accessdata.fda.gov
High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation	SGN	2	Manufacturer	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Manufacturer	accessdata.fda.gov
Marker, Skin	FZZ	1	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite	OUP	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	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
September 17, 2024	K242186	Neo Sculptor (OF-NEO001)	NGX	Substantially Equivalent	Ofan Intelligent Technology (Guangzhou) Co. , Ltd.	accessdata.fda.gov
April 23, 2021	K202257	Dermatological Diode Laser Systems	GEX	Substantially Equivalent	Zhuolu Jontelaser Manufacturing Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 17, 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.