RehaStim 2 / RehaMove 2 FES00005

GUDID 04260397620168

powered muscle stimulator (8 channels) for use as stand-alone device as well as in combination with powered exerciser with predefined programs for stimulation of muscles of the musculoskeletal system

HASOMED GmbH

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04260397620168
• NIH Device Record Key: 26228a7e-8c84-4474-ac30-e7801c15278c
• Commercial Distribution Discontinuation: 2018-04-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RehaStim 2 / RehaMove 2
• Version Model Number: FES00005
• Catalog Number: FES00005
• 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	04260397620168 [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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-13

Devices Manufactured by HASOMED GmbH

• 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: 2019-10-23powered muscle stimulator (8 channels) for use as stand-alone device as well as in combination with powered exerciser with predefined programs for stimulation of muscles of the musculoskeletal system
• 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