Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615330

FEI Number

3002316112

Entity Name

THERMOTEX THERAPY SYSTEMS LTD.

City/State/Country

CALGARY Alberta, CA

Establishment Address

15, 6115 - 4 ST. S.E., CALGARY Alberta T2H 2H9, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

THERMOTEX THERAPY SYSTEMS LTD. (Owner Number: 9032260)

Owner / Operator Contact Address

15, 6115 - 4 ST., S.E., --, CALGARY, CA-AB T2H 2H9, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092589

PMA Number

N/A

All Registered Proprietary Names

Thermotex Heat Therapy Systems Thermotex Therapy Systems Thermotex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2011-01-19
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2011-01-19

Official Correspondent

Joseph Sereda

US Agent Details

Jessica Reinig Email: jessica@alikaihealth.com Phone: (260) 4338499

Related Public Records

Same Entity

THERMOTEX THERAPY SYSTEMS LTD.

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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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3013284090	SHENZHEN H&T INTELLIGENT CONTROL CO., LTD.	Shenzhen Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615330. Last updated year: 2026. Please use registration number 9615330 when referencing this establishment in official correspondence.