Model: K6133
DI: 06978182240450
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-11
Current Version: 2026-05-19
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
57e727ad-79e3-4b6e-b92a-b48ec030ecee
Distribution Status:
In Commercial Distribution
DUNS Number:
715164995
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
Yes
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
06978182240450
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
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Premarket Submissions
Submission Number:
K250784
Supplement Number:
000