FDA UDI In Commercial Distribution 🇺🇸 United States

RehaStim 2

DI: 04260397620670 · Model: FES01050 · HASOMED GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
RehaStim 2
Primary DI
04260397620670
Version / Model
FES01050
Catalog Number
FES01050
Company Name
HASOMED GmbH
Labeler DUNS
341439008
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-06-05
Public Version
1
Public Version Date
2018-07-06
Public Version Status
New
Public Device Record Key
37dbec03-1adb-43c0-9dbb-4a1fed8578a5

Device Description

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

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GZI Stimulator, Neuromuscular, External Functional

GMDN Terms

Code Name
35725 Gait-enhancement electrical stimulation system, external

Identifiers

Type ID
Primary 04260397620670