AccessGUDID - DEVICE: TensCare (05033435136933)

GUDID

Device Identifier (DI) Information

Brand Name: TensCare
Version or Model: Form Duo
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TENSCARE LIMITED

Primary DI Number: 05033435136933
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 569403736 *Terms of Use

Device Description: Form Duo is a variant of the Perfect EMS medical device and is identical to the Form unit but comes with two stimulators. It has one programme identical to one programme on the Perfect EMS. Form is an innovative electrical muscle stimulator used to target muscles for local and wholebody muscle recovery. The stimulator delivers small electrical impulses via smart, body-worn electrodes, designed to optimise muscle coverage, motor point activation and elicit small muscle contractions. This type of ‘active recovery’ helps the muscle recovery process without causing cardiovascular fatigue. Enhance your recovery routine and return to activity faster with Form.

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

[?]

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: 13d15730-8473-4b1a-b727-e99bb10b9ac1
Public Version Date: August 02, 2024
Public Version Number: 1
DI Record Publish Date: July 25, 2024