HomeUSAInnovative Neurotronics, Inc.

Innovative Neurotronics, Inc.

USA · Reno
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Hong Kong, Israel, Russia — 7 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
3listed device types
Class I 2Class II 1Class III 0
plus 5 registration records and 3 510(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
1 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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, 3 510(k), 0 PMA, 3 excluded
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: INNOVATIVE NEUROTRONICS INC. · INNOVATIVE NEUROTRONICS

Company information

Country
USA
City
Reno

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

12005 · K052329
12013 · K123972
12014 · K140886

FDA listed device types

Stimulator, Neuromuscular, External Functional 1Joint, Knee, External Limb Component 1Monitor, Orthotic/Prosthetic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK140886WALKAIDE SYSTEM2014-08-08
USK123972WALKAIDE SYSTEM2013-04-01
USK052329WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-10002005-09-21

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