AccessGUDID - DEVICE: SofWave Pure Impact Wireless Stimulation Module (07290018152140)

GUDID

Device Identifier (DI) Information

Brand Name: SofWave Pure Impact Wireless Stimulation Module
Version or Model: FG00014
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG00014
Company Name: SOFWAVE MEDICAL LTD

Primary DI Number: 07290018152140
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531962539 *Terms of Use

Device Description: Powered Muscle Stimulator (EMS)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232455	000
K241685	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 Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4707d823-1b76-4ce8-b47e-301a77a34197
Public Version Date: November 08, 2024
Public Version Number: 2
DI Record Publish Date: January 07, 2024