SofWave Pure Impact Stimulation Modules Charging Station

Primary DI
07290018152133
Brand
SofWave Pure Impact Stimulation Modules Charging Station
Company
SOFWAVE MEDICAL LTD
Model
FG00013
Catalog number
FG00013
Device description
Charging station for Powered Muscle Stimulator (EMS)
Published
2024-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
NXGFluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXGFluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And DeletionUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232455000
K241685000
K250146000
K251746000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232455000SofWave SystemSofwave Medical, Ltd.2023-12-14OHV
K241685000SofWave SystemSofwave Medical, Ltd.2024-08-07NGX
K250146000SofWave SystemSofwave Medical, Ltd.2025-04-18NGX
K251746000Pure ImpactSofwave Medical, Ltd.2025-07-02NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018152133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018152133072900181521337290018152133

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
531962539
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018152096SofWave Pure Impact Wireless Stimulation ModuleFG00014-RFG00014-R2026-02-12
07290018152164Pure ImpactKT00040KT000402026-02-01
07290018152140SofWave Pure Impact Wireless Stimulation ModuleFG00014FG000142024-01-07
17290018152154SofWave Pure Impact Electode PadsFG00015FG000152024-01-07
07290018152171Pure Impact Touch control ModuleFG00016FG000162025-09-08
07290018152003SofwaveFG00001FG000012019-11-10
07290018152089Sofwave ApplicatorFG00004FG000042025-02-16
07290018152058Sofwave ApplicatorFG00003FG000032023-04-24
07290018152010Sofwave ApplicatorFG00002FG000022019-11-10
07290018152065Sofwave ApplicatorFG00003-RFG00003-R2023-04-24
07290018152027Sofwave ApplicatorFG00002-RFG00002-R2021-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290018152003SofwaveSOFWAVE MEDICAL LTDNXG2019-11-10