MedtechSourcebook

CLEARLAKE-TECH INC

Contract manufacturer · Clear Lake, SD

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
1721293 (openFDA record; or search FDA's registration database)
FEI number
1721293
Registered for
FDA registration year 2026
Establishment types
Manufacturer for export only; Manufacturer; Contract manufacturer
Owner or operator
ClearLake-Tech Inc (FDA owner/operator no. 10093487)
Registered address
205 Hwy 22 E, Clear Lake, SD 57226
Contract listings
7 device listings, 12 product codes, first listed May 23, 2025
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
EGJDevice, Iontophoresis, Other UsesClass IIPhysical medicineContract manufacturingMay 23, 2025
GZIStimulator, Neuromuscular, External FunctionalClass IINeurologyContract manufacturingMay 23, 2025
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefClass IINeurologyContract manufacturingMay 23, 2025
HCCDevice, BiofeedbackClass IINeurologyContract manufacturingMay 23, 2025
ILYLamp, Infrared, Therapeutic HeatingClass IIPhysical medicineContract manufacturingMay 23, 2025
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatClass IIPhysical medicineContract manufacturingMay 23, 2025
IPFStimulator, Muscle, PoweredClass IIPhysical medicineContract manufacturingMay 23, 2025
ISAMassager, Therapeutic, ElectricClass IPhysical medicineContract manufacturingMay 23, 2025
JOWSleeve, Limb, CompressibleClass IICardiovascularContract manufacturingMay 23, 2025
KTBDevice, Iontophoresis, Specific UsesClass IIPhysical medicineContract manufacturingMay 23, 2025
LIHInterferential Current TherapyClass IINeurologyContract manufacturingMay 23, 2025
LOFStimulator, Bone Growth, Non-InvasiveClass IIOrthopedicContract manufacturingMay 23, 2025