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Auvon

FDA UDI

Class II (US FDA UDI)

by Shenzhen Yuwen E-Commerce Co., Ltd.

Identity

Trade Name
AUVON FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. FDA UDI
Model / Reference
AS8012 FDA UDI
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, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. FDA UDI

Identifiers

Primary DI / UDI-DI
06971292000594 FDA UDI
FDA Product Code
NUH FDA UDI
NGX FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
890.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

Auvon by Shenzhen Yuwen E-Commerce Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 71447e42-4f9b-455d-b6e4-c292ca21331a 34 fields · synced May 30, 2026