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NORMATEC INDUSTRIES, LP

USA · Watertown

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia — 5 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

4listed device types

Class I 0Class II 4Class III 0

plus 12 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

6active device licences

Class II 6

11 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 2IIa 4

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 States12 registration records, 9 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: NORMATEC INDUSTRIES, LP

FDA 510(k) clearances by year

12012

22016 · K161346

22018 · K183169

22022 · K221666

12024 · K240122

12025 · K251905

FDA listed device types

Pack, Hot Or Cold, Water Circulating 1Sleeve, Limb, Compressible 1Pad, Heating, Powered 1Massager, Powered Inflatable Tube 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251905	Normatec Elite Hip	2025-09-18
US	K240122	Normatec Elite	2024-03-21
US	K221666	Normatec Go	2022-07-14
BR	80633669009	Normatec Elite	Class II
BR	80633669002	NORMATEC 3	Class II
CA	97691	PULSE SYSTEM	Class II
CA	97695	PULSE PRO SYSTEM	Class II
CA	102356	NORMATEC 2.0	Class II

NORMATEC INDUSTRIES, LP

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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