AccessGUDID - DEVICE: DEKA PHYSIQ (08057017760535)

GUDID

Device Identifier (DI) Information

Brand Name: DEKA PHYSIQ
Version or Model: M120F1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M120F1
Company Name: EL.EN. SPA

Primary DI Number: 08057017760535
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436887608 *Terms of Use

Device Description: The PHYSIQ is a device provided with 4 handpieces by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.

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

[?]

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
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief
IPF	Stimulator, Muscle, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202079	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
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 1060 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e977a89b-2b4b-4b05-97a8-a1f17ee0d369
Public Version Date: June 02, 2023
Public Version Number: 3
DI Record Publish Date: December 11, 2020