AccessGUDID - DEVICE: Pro Comfort TENS Unit (00850632007188)

GUDID

Device Identifier (DI) Information

Brand Name: Pro Comfort TENS Unit
Version or Model: SM9128
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7188
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00850632007188
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: Features: 1.LCD screen 2.2 output ports 3.10-60 minutes adjustable 4.Rechargeable built-in lithium battery Functions: 1.Eliminate body fatigue 2.Relax muscles and joints 3.Improve blood circulation 4.Increase metabolism and prevent many work related symptoms Specifications 1.Power/voltage: 3.7V 2.Massage issuing frequency: 1~110Hz 3.Consumed current: 40mA 4.Status adjustment: 6 kinds of status

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):	Yes
Over the Counter (OTC):	No
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

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Product Code	Product Code Name
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121719	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
Handling Environment Temperature: between -20 and 55 Degrees Celsius
Handling Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8946747a-51a5-4d4e-ad77-7c4f9b7a4983
Public Version Date: June 02, 2023
Public Version Number: 8
DI Record Publish Date: November 15, 2017