HAL for Medical Use

GUDID 04560340090940

Number of legs: Double Leg length: Short Hip width: Medium

CYBERDYNE, INC.

Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton Neuro-controlled ambulation exoskeleton
Primary Device ID04560340090940
NIH Device Record Key11bb4060-8542-4b23-a659-b34956204226
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAL for Medical Use
Version Model NumberHAL-ML05-DSMUS
Company DUNS714480766
Company NameCYBERDYNE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS104560340090940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCCDevice, Biofeedback

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-04
Device Publish Date2019-02-01

On-Brand Devices [HAL for Medical Use]

04560340091091Number of legs: Double Leg length: eXtra long Hip width: Wide
04560340091084Number of legs: Double Leg length: Long Hip width: Wide
04560340091077Number of legs: Double Leg length: Medium Hip width: Wide
04560340091060Number of legs: Double Leg length: Short Hip width: Wide
04560340090971Number of legs: Double Leg length: eXtra long Hip width: Medium
04560340090964Number of legs: Double Leg length: Long Hip width: Medium
04560340090957Number of legs: Double Leg length: Medium Hip width: Medium
04560340090940Number of legs: Double Leg length: Short Hip width: Medium

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