Model: N20-PRO-SYS-1:1
DI: 00850051584048
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1391a66c-c77a-4eba-b832-b46a66bf49f7
Distribution Status:
In Commercial Distribution
DUNS Number:
128136644
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
00850051584048
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
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
Premarket Submissions
Submission Number:
K223797
Supplement Number:
000