Device
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck,upper extremities (arm), lower extre...
Manufacturer
UAN HEALTHCARE LIMITED
UAN HEALTHCARE LIMITED
Model: TP2208C
DI: 00850080988404
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-04-29
Current Version: 2026-05-07
Description
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck,upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9df761b7-0517-47cf-926b-92586010dbb0
Distribution Status:
In Commercial Distribution
DUNS Number:
765349382
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 - Device ID:
10850080988401
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
40
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00850080988404
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00850080988404
Item #2 - Device ID Type:
Primary
Item #2 - Device ID 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
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter