FDA UDI In Commercial Distribution 🇺🇸 United States

AUVON

DI: 00850080988138 · Model: TP2408C · UAN HEALTHCARE LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
AUVON
Primary DI
00850080988138
Version / Model
TP2408C
Company Name
UAN HEALTHCARE LIMITED
Labeler DUNS
765349382
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-03-19
Public Version
1
Public Version Date
2026-03-27
Public Version Status
New
Public Device Record Key
82ff4adb-8318-4ba5-85a5-f02aaddebca7

Device Description

Transcutaneous Electrical Nerve Stimulation (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. Electrical Muscle Stimulation (EMS): The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Unsafe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NGX Stimulator, Muscle, Powered, For Muscle Conditioning
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

GMDN Terms

Code Name
35372 Analgesic transcutaneous electrical nerve stimulation system

Identifiers

Type ID
Package 10850080988135
Primary 00850080988138

Customer Contacts