RehaStim 2 for Hocoma FES01050

GUDID 04260397620427

External Functional Neuromuscular Stimulator (8 channels)

HASOMED GmbH

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• Primary Device ID: 04260397620427
• NIH Device Record Key: b2a7f532-f549-4d23-9761-4c491cdfc816
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RehaStim 2 for Hocoma
• Version Model Number: FES01050
• Catalog Number: FES01050
• Company DUNS: 341439008
• Company Name: HASOMED GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04260397620427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112844

FDA Product Code

• GZI: Stimulator, Neuromuscular, External Functional

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-30
• Device Publish Date: 2020-11-22

Devices Manufactured by HASOMED GmbH

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• 04260397620427 - RehaStim 2 for Hocoma: 2020-11-30External Functional Neuromuscular Stimulator (8 channels)
• 04260397620427 - RehaStim 2 for Hocoma: 2020-11-30 External Functional Neuromuscular Stimulator (8 channels)
• 04260397621110 - DigiTrainer: 2020-08-20 Exerciser, Finger, Powered
• 04260397621127 - DigiTrainer S: 2020-08-20 Exerciser, Finger, Powered
• 04260397620168 - RehaStim 2 / RehaMove 2: 2019-10-23 powered muscle stimulator (8 channels) for use as stand-alone device as well as in combination with powered exerciser with prede
• 04260397620670 - RehaStim 2: 2018-07-06 External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with
• 04260397620342 - RehaStim 2: 2018-03-29 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 Keyboard: 2018-03-29 RehaCom Keyboard