HomeUSANOVA ORTHO-MED, INC.

NOVA ORTHO-MED, INC.

USA · North Aurora
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, South Korea — 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
10listed device types
Class I 9Class II 1Class III 0
plus 10 registration records and 1 510(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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
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, 1 510(k), 0 PMA, 39 excluded
Brazil0 confirmed, 7 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 7 excluded
Manufacturer names merged into this page: NOVA ORTHO-MED, INC.

Company information

Country
USA
City
North Aurora

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

12006 · K061273

FDA listed device types

showing 8 of 10
Protector, Skin Pressure 1Adaptor, Hygiene 1Footrest, Wheelchair 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1Armrest, Wheelchair 1Chair And Table, Medical 1Components, Wheelchair 1Walker, Mechanical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK0612737000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L2006-05-23

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