HomeUSAEkso Bionics, Inc.

Ekso Bionics, Inc.

USA · San Rafael
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Singapore, Australia — 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
5listed device types
Class I 4Class II 1Class III 0
plus 10 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
0active device licences
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
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, 4 510(k), 0 PMA
Manufacturer names merged into this page: EKSO BIONICS

Company information

Country
USA
City
San Rafael

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

22016 · K161443
12020 · K200574
12022 · K220988

FDA listed device types

Orthosis, Limb Brace 1Walker, Mechanical 1Treadmill, Powered 1Components, Exercise 1Powered Exoskeleton 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220988EksoNR2022-06-09
USK200574EksoNR2020-06-19
USK161443Ekso™ (version 1.1) and Ekso GT™ (version 1.2)2016-07-19

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