AUVON - TENS: To be used for temporary relief of pain - Shenzhen Yuwen E-Commerce Co., Ltd.

Duns Number:544559614

Device Description: TENS: To be used for temporary relief of pain associated with sore and aching muscles in t TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.PMS:It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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More Product Details

Catalog Number

-

Brand Name

AUVON

Version/Model Number

SM9126

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Device Record Status

Public Device Record Key

c6c19f6d-9003-434c-a5ce-3ba69d922685

Public Version Date

September 01, 2021

Public Version Number

1

DI Record Publish Date

August 24, 2021

Additional Identifiers

Package DI Number

16971292000553

Quantity per Package

48

Contains DI Package

06971292000556

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SHENZHEN YUWEN E-COMMERCE CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 99