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THERMOTEK, INC.

USA · Flower Mound

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 1Class II 5Class III 0

plus 5 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class II 5

8 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States5 registration records, 4 510(k), 0 PMA

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: THERMOTEK, INC. · THERMOTEK INC.

FDA 510(k) clearances by year

21995 · K945853

12006 · K061866

12010 · K103247

FDA listed device types

Sleeve, Limb, Compressible 1Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat 1Scalp Cooling System 1Pack, Hot Or Cold, Water Circulating 1Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat 1Orthosis, Limb Brace 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K103247	VASCUCOMP	2010-12-10
US	K061866	NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS	2006-08-22
US	K945853	THERMOTEK H-300	1995-10-05
CA	83450	ARTEK AIR THERAPY SYSTEM	Class II
CA	83451	ARTEK SPOT THERAPY SYSTEM	Class II
CA	83490	VASCUTHERM 3 THERAPY DEVICE	Class II

THERMOTEK, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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