HomeUSAU.S. Therapy Products, Inc.

U.S. Therapy Products, Inc.

USA · Edina
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan — 4 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
8listed device types
Class I 6Class II 2Class III 0
plus 10 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
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 States10 registration records, 13 510(k), 0 PMA, 66 excluded
Brazil1 confirmed, 3 excluded
Saudi Arabia1 confirmed, 0 excluded
Canada0 confirmed, 17 excluded
Manufacturer names merged into this page: Danyang Rapid Aid Hot and Cold Therapy Products Co. Ltd · NATIONAL THERAPY PRODUCTS INC. · DANYANG RAPID AID HOT AND COLD THERAPY PRODUCTS CO. LTD · Danyang Rapid Aid Hot and Cold Therapy Products Co.,Ltd.

Company information

Country
USA
City
Edina

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11980
11981
11987
11988
11989
11993
21995
11998
12001
12002
12006
12013

FDA listed device types

Infant Heel Warmer (Chemical Heat Pack) 1Accessory, Surgical Apparel 1Bag, Ice 1Pack, Hot Or Cold, Disposable 1Adhesive Backed Thermal Skin Patches 1Pack, Hot Or Cold, Reusable 1Media, Coupling, Ultrasound 1Transducer, Ultrasonic, Diagnostic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK131387WRIGHT GRADIENT 52 - TORSO2013-11-20
USK060134APOLLO IR HEAT LAMP SYSTEM2006-03-21
USK013212WAVELENGHT ULTRASOUND LOTION2002-02-25
BR80758210115BOLSA TERMICAClass I
SAME0000002314SFDAA00005RAPID RELIEF INFANT HEEL WARMER

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