DEVICE: RehaStim 2 / RehaMove 2 (04260397620168)

Device Identifier (DI) Information

RehaStim 2 / RehaMove 2
FES00005
In Commercial Distribution
FES00005
HASOMED GmbH
04260397620168
GS1

1
341439008 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Physical therapy electrical stimulation system, battery-powered An assembly of battery-powered devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical stimulation of calf muscles to prevent venous thrombosis, and/or to maintain or increase range of motion.
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FDA Product Code

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Product Code Product Code Name
GZI Stimulator, Neuromuscular, External Functional
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

26228a7e-8c84-4474-ac30-e7801c15278c
March 29, 2018
2
September 13, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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