CLEARLAKE-TECH INC

FDA Device Registration & Listing · Clear Lake, SD, US · Registration 1721293

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1721293
FEI Number
1721293
Entity Name
CLEARLAKE-TECH INC
City/State/Country
Clear Lake, SD, US
Establishment Address
205 Hwy 22 E, Clear Lake, SD 57226, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ClearLake-Tech Inc (Owner Number: 10093487)
Owner / Operator Contact Address
205 Hwy 22 E, Clear Lake, SD 57226, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K223775
PMA Number
N/A

All Registered Proprietary Names

Dupel Blue Ionto Electrode Premium Recovery Electrodes

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LOF Stimulator, Bone Growth, Non-Invasive Orthopedic Class 2 890.5870 2025-05-23
EGJ Device, Iontophoresis, Other Uses Physical Medicine Class 2 890.5525 2025-05-23
EGJ Device, Iontophoresis, Other Uses Physical Medicine Class 2 890.5525 2025-05-23
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2025-05-23
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5860 2025-05-23
LIH Interferential Current Therapy Neurology Class 2 882.5890 2025-05-23
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2025-05-23
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2025-05-23
HCC Device, Biofeedback Neurology Class 2 882.5050 2025-05-23
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2025-05-23
EGJ Device, Iontophoresis, Other Uses Physical Medicine Class 2 890.5525 2025-05-23
KTB Device, Iontophoresis, Specific Uses Physical Medicine Class 2 890.5525 2025-05-23
KTB Device, Iontophoresis, Specific Uses Physical Medicine Class 2 890.5525 2025-05-23
EGJ Device, Iontophoresis, Other Uses Physical Medicine Class 2 890.5525 2025-05-23
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2025-05-23

Official Correspondent

Amaris Ajamil

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ClearLake-Tech Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K842483 Santa Barbara Medco, Inc. SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC 1984-08-31
K122948 Gemore Technology Co, Ltd. GEM-STIM COMBO STIMULATOR 2012-12-21
K033455 Biomedical Life Systems, Inc. ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 2004-01-15
K810593 Medical Devices, Inc. NEUROPAC ULTRA I 1981-03-13
K873418 Bodylog, Inc. BODYLOG STRESS REDUCTION PACKAGE 1987-12-17

Similar Registrations

Registration Number Establishment Name Location
3017264244 DJO, LLC Carlsbad, CA, US
3007611554 CREATION TECHNOLOGIES LTD Mississauga Ontario, CA
2242816 EBI, LLC PARSIPPANY, NJ, US
2183449 ORTHOFIX US LLC Lewisville, TX, US
3016050940 Olive Branch Distribution Center Olive Branch, MS, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1721293. Last updated year: 2026. Please use registration number 1721293 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.