TensCare - Sports TENS 2 is a hand-held, home-use device - TENSCARE LIMITED

Duns Number:569403736

Device Description: Sports TENS 2 is a hand-held, home-use device designed to relief of pain and improve and f Sports TENS 2 is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Sports TENS 2 is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles.The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has fifty preset treatment programs and four manually adjustable programmes are available.

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More Product Details

Catalog Number

K-ST2

Brand Name

TensCare

Version/Model Number

Sports TENS 2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

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

K200694

Product Code Details

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Device Record Status

Public Device Record Key

379b6587-2347-4dad-920a-d1e15747a0bb

Public Version Date

March 09, 2022

Public Version Number

1

DI Record Publish Date

March 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TENSCARE LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7