Primary Device ID | B168EKSOUE0 |
NIH Device Record Key | 01422b72-03f4-4005-a33d-44f9b7fcafc3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EksoUE |
Version Model Number | EKSOUE |
Catalog Number | EKSOUE |
Company DUNS | 190152921 |
Company Name | EKSO BIONICS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B168EKSOUE0 [Primary] |
PKS | Exerciser, Non-Measuring For Stroke Rehabilitation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-11 |
Device Publish Date | 2022-03-03 |
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B168EKSONR0 - EksoNR | 2022-03-11 EKSO BIONICS SYSTEM, Ekso NR |
B168EKSOUE0 - EksoUE | 2022-03-11EKSO BIONICS SYSTEM, Ekso UE |
B168EKSOUE0 - EksoUE | 2022-03-11 EKSO BIONICS SYSTEM, Ekso UE |
B1431200000 - Ekso | 2018-03-29 The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is w |