RehaStim2 FES01092

GUDID 04260397620410

External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician. - manufactured for use in system

HASOMED GmbH

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Primary Device ID04260397620410
NIH Device Record Key0795162a-6b9a-425f-a88b-ea9457117ed4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRehaStim2
Version Model NumberFES01092
Catalog NumberFES01092
Company DUNS341439008
Company NameHASOMED GmbH
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
GS104260397620410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZIStimulator, Neuromuscular, External Functional

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-30
Device Publish Date2020-11-22

Devices Manufactured by HASOMED GmbH

04260397620410 - RehaStim22020-11-30External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician. - manufactured for use in system
04260397620410 - RehaStim22020-11-30 External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with
04260397620427 - RehaStim 2 for Hocoma2020-11-30 External Functional Neuromuscular Stimulator (8 channels)
04260397621110 - DigiTrainer2020-08-20 Exerciser, Finger, Powered
04260397621127 - DigiTrainer S2020-08-20 Exerciser, Finger, Powered
04260397620168 - RehaStim 2 / RehaMove 22019-10-23 powered muscle stimulator (8 channels) for use as stand-alone device as well as in combination with powered exerciser with prede
04260397620670 - RehaStim 22018-07-06 External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with
04260397620342 - RehaStim 22018-03-29 External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with
04260397620960 - RehaCom Cognitive Therapy Panel, RehaCom Keyboard2018-03-29 RehaCom Keyboard
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