Pure Impact KT00040

GUDID 07290018152164

Powered Muscle Stimulator (EMS) KIT. The KIT contains 3 components (all individually registered in GUDID): (SN) FG00013 with UDI: 07290018152133 (SN) FG00014 with UDI: 07290018152140 (SN) FG00015 with UDI: 17290018152154

SOFWAVE MEDICAL LTD

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 07290018152164
• NIH Device Record Key: 69eff0f4-0b23-4674-b13b-b0caa5e47389
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure Impact
• Version Model Number: KT00040
• Catalog Number: KT00040
• Company DUNS: 531962539
• Company Name: SOFWAVE MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018152164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232455

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-09
• Device Publish Date: 2026-02-01

Devices Manufactured by SOFWAVE MEDICAL LTD

• 07290018152164 - Pure Impact: 2026-02-09Powered Muscle Stimulator (EMS) KIT. The KIT contains 3 components (all individually registered in GUDID): (SN) FG00013 with UDI: 07290018152133 (SN) FG00014 with UDI: 07290018152140 (SN) FG00015 with UDI: 17290018152154
• 07290018152164 - Pure Impact: 2026-02-09 Powered Muscle Stimulator (EMS) KIT. The KIT contains 3 components (all individually registered in GUDID): (SN) FG00013 with UDI
• 07290018152171 - Pure Impact Touch control Module: 2025-09-16 Touch control Module (all in one PC and screen) for Powered Muscle Stimulator (EMS)
• 07290018152089 - Sofwave Applicator: 2025-02-24 The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System consists of two main functional c
• 07290018152133 - SofWave Pure Impact Stimulation Modules Charging Station: 2024-01-15 Charging station for Powered Muscle Stimulator (EMS)
• 07290018152140 - SofWave Pure Impact Wireless Stimulation Module: 2024-01-15 Powered Muscle Stimulator (EMS)
• 17290018152154 - SofWave Pure Impact Electode Pads: 2024-01-15 Electrode Pads for Powered Muscle Stimulator (EMS)
• 07290018152058 - Sofwave Applicator: 2023-05-02 The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System consists of two main functional c
• 07290018152065 - Sofwave Applicator: 2023-05-02 This applicator is the refurbish version of the small (precise) applicator, designed to allow the user treatment flexibility and