Model: KTR-2301
DI: 06924607702997
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-04-30
Current Version: 2026-05-08
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
280c490f-39fa-4d4a-8849-ecdfc4a212b7
Distribution Status:
In Commercial Distribution
DUNS Number:
544395368
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:
06924607702997
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35372
Name: Analgesic transcutaneous electrical nerve stimulation system
Definition:
An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.
FDA Product Codes
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Premarket Submissions
Submission Number:
K242332
Supplement Number:
000