AccessGUDID - DEVICE: Guardian Unity (B73643211)

GUDID

Device Identifier (DI) Information

Brand Name: Guardian Unity
Version or Model: 01GS90
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01GS90
Company Name: SPECTRAMED, INC.

Primary DI Number: B73643211
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 793161472 *Terms of Use

Device Description: 2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device output 90mA with 7 pre-set programs

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":	Yes
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
IPF	Stimulator, Muscle, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020637	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 Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 101.3 KiloPascal
Storage Environment Temperature: between -6 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Depth: 1.1 Inch
Length: 5 Inch
Width: 2.6 Inch
Weight: 0.46875 Pound

Device Record Status

Public Device Record Key: 773fe51f-005d-401d-abde-ba7f88116a77
Public Version Date: June 02, 2023
Public Version Number: 6
DI Record Publish Date: April 01, 2019