EksoUE EKSOUE

GUDID B168EKSOUE0

EKSO BIONICS SYSTEM, Ekso UE

EKSO BIONICS, INC.

Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser Shoulder continuous passive motion exerciser
Primary Device IDB168EKSOUE0
NIH Device Record Key01422b72-03f4-4005-a33d-44f9b7fcafc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEksoUE
Version Model NumberEKSOUE
Catalog NumberEKSOUE
Company DUNS190152921
Company NameEKSO BIONICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB168EKSOUE0 [Primary]

FDA Product Code

PKSExerciser, Non-Measuring For Stroke Rehabilitation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-11
Device Publish Date2022-03-03

Devices Manufactured by EKSO BIONICS, INC.

M704501100000 - Indego2023-10-23 Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
M704501110001 - Indego Therapy2023-10-23 Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individu
B168EKSOGT0 - EksoGT2022-03-11 EKSO BIONICS SYSTEM, Ekso GT
B168EKSONR0 - EksoNR2022-03-11 EKSO BIONICS SYSTEM, Ekso NR
B168EKSOUE0 - EksoUE2022-03-11EKSO BIONICS SYSTEM, Ekso UE
B168EKSOUE0 - EksoUE2022-03-11 EKSO BIONICS SYSTEM, Ekso UE
B1431200000 - Ekso2018-03-29 The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is w

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.