Device
TENS (Transcutaneous Electric Nerve Stimulation):
Manufacturer
Shenzhen Jiantuo Electronics Co., Ltd
Shenzhen Jiantuo Electronics Co., Ltd
Model: JT8012B
DI: 06978452680078
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-21
Current Version: 2026-05-29
Distribution End: 2030-06-21
Description
TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back,neck,abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS (Electrical Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b3cc87e5-9e0b-4df9-af93-37e61c44df00
Distribution Status:
In Commercial Distribution
DUNS Number:
625496494
Device Count:
1
DM Exempt:
No
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:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Carton
Item #1 - Device ID:
16978452680075
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
48
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06978452680078
Item #1 - Pkg Discontinue Date:
2026-06-22
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06978452680078
Item #2 - Device ID Type:
Primary
Item #2 - Device ID 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
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
Premarket Submissions
Submission Number:
K250053
Supplement Number:
000