Data / Medical devices / United States / Clearlake-Tech Inc

Clearlake-Tech Inc: FDA-registered device maker in Clear Lake, SD, United States, 1 510(k) clearance

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

Clearlake-Tech Inc is registered with the FDA (registration 1721293) in Clear Lake, SD, United States. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 3, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1721293
Address: 205 Hwy 22 E, Clear Lake, SD, United States, 57226
Owner or operator: ClearLake-Tech Inc (10093487)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export
First device listed: May 23, 2025
Registered through: 2026
Brand names listed: Dupel Blue Ionto Electrode, Premium Recovery Electrodes

Devices it lists

Device	Product code	Class	Role	Source
Device, Biofeedback	HCC	2	Contract manufacturer	accessdata.fda.gov
Device, Iontophoresis, Other Uses	EGJ	2	Contract manufacturer, Manufacturer for export	accessdata.fda.gov
Device, Iontophoresis, Specific Uses	KTB	2	Contract manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Contract manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Contract manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Contract manufacturer	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Bone Growth, Non-Invasive	LOF	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Contract manufacturer, Manufacturer for export	accessdata.fda.gov
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	IMG	2	Contract 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
January 3, 2023	K223775	EZ-STIK Electrodes	GXY	Substantially Equivalent	South Dakota Partners	accessdata.fda.gov

Compare with other makers

Updated January 3, 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.