Device
Stim2Go incl. stimulator, 2 & 5 channel cable, adapter cable 1:2, charging cable, strap
Manufacturer
Pajunk GmbH Medizintechnologie
Pajunk GmbH Medizintechnologie
Model: 9151-10-00
Catalog: 9151-10-00
DI: 04048223122235
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Stim2Go incl. stimulator, 2 & 5 channel cable, adapter cable 1:2, charging cable, strap
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1ef437ba-8428-437d-a442-45daaad289b6
Distribution Status:
In Commercial Distribution
DUNS Number:
317654283
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04048223122235
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46573
Name: Physical therapy transcutaneous neuromuscular electrical stimulation system
Definition:
An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.
FDA Product Codes
IPF
Stimulator, muscle, powered
Premarket Submissions
Submission Number:
K230701
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
5
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
35
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
15
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
93
Item #2 - Storage Handling Type:
Storage Environment Humidity