Digital Portable EMS

GUDID 10660584000215

Dynatronics Corporation

Physical therapy transcutaneous neuromuscular electrical stimulation system

Primary Device ID	10660584000215
NIH Device Record Key	89b0d22e-27f0-4932-9526-782d9fa4e07f
Commercial Distribution Discontinuation	2019-03-13
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Digital Portable EMS
Version Model Number	DGEMS
Company DUNS	113399125
Company Name	Dynatronics Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter
Width	61.5 Millimeter
Length	108 Millimeter
Height	25 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10660584000215 [Primary]

FDA Product Code

IPF	Stimulator, Muscle, Powered

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-10-23
Device Publish Date	2016-09-24

On-Brand Devices [Digital Portable EMS]

10660584000420	DGEMS
10660584000215	DGEMS