SofWave Pure Impact Electode Pads FG00015

GUDID 17290018152154

Electrode Pads for Powered Muscle Stimulator (EMS)

SOFWAVE MEDICAL LTD

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID17290018152154
NIH Device Record Key15aa9924-9429-451a-91b6-79b9983050d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSofWave Pure Impact Electode Pads
Version Model NumberFG00015
Catalog NumberFG00015
Company DUNS531962539
Company NameSOFWAVE MEDICAL LTD
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107290018152157 [Unit of Use]
GS117290018152154 [Primary]
GS127290018152151 [Package]
Package: Carton (Shipper) [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGXStimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-15
Device Publish Date2024-01-07

Devices Manufactured by SOFWAVE MEDICAL LTD

07290018152133 - SofWave Pure Impact Stimulation Modules Charging Station2024-01-15 Charging station for Powered Muscle Stimulator (EMS)
07290018152140 - SofWave Pure Impact Wireless Stimulation Module2024-01-15 Powered Muscle Stimulator (EMS)
17290018152154 - SofWave Pure Impact Electode Pads2024-01-15Electrode Pads for Powered Muscle Stimulator (EMS)
17290018152154 - SofWave Pure Impact Electode Pads2024-01-15 Electrode Pads for Powered Muscle Stimulator (EMS)
07290018152058 - Sofwave Applicator2023-05-02 The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System consists of two main functional c
07290018152065 - Sofwave Applicator2023-05-02 This applicator is the refurbish version of the small (precise) applicator, designed to allow the user treatment flexibility and
07290018152027 - Sofwave Applicator2021-06-04
07290018152003 - Sofwave2020-02-06 FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION
07290018152010 - Sofwave Applicator2020-02-06

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