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

Gait-enhancement electrical stimulation system, external

• Primary Device ID: 04260397620410
• NIH Device Record Key: 0795162a-6b9a-425f-a88b-ea9457117ed4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RehaStim2
• Version Model Number: FES01092
• Catalog Number: FES01092
• 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	04260397620410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162683

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

• 04260397620410 - RehaStim2: 2020-11-30External 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 - RehaStim2: 2020-11-30 External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with
• 04260397620427 - RehaStim 2 for 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