AccessGUDID - DEVICE: TensCare (05033435136209)

GUDID

Device Identifier (DI) Information

Brand Name: TensCare
Version or Model: Unifit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K-UNIFIT
Company Name: TENSCARE LIMITED

Primary DI Number: 05033435136209
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 569403736 *Terms of Use

Device Description: Unifit combines the treatment capabilities of a TENS device, an EMS or NMES device, and a relaxing massage stimulator in one unit. It sends a small and gentle stimulation (similar to your natural nerve impulses) to the muscles being treated via two or four auto-adhesive electrode pads, in order to help you to firm and tone your body. Unifit is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Unifit 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 preset treatment programs and manually adjustable programmes are available.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200694	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 252d985b-f93a-4cb9-ad3e-6e50dd32a0bc
Public Version Date: November 13, 2023
Public Version Number: 1
DI Record Publish Date: November 03, 2023