SWISS DOLORCLAST FT-250#A/002

GUDID 07613353226053

DolorClast Radial

E.M.S. Electro Medical Systems S.A.

Pneumatic orthopaedic extracorporeal shock wave therapy system

• Primary Device ID: 07613353226053
• NIH Device Record Key: 02bc0a5f-957f-4992-b6c5-4ca9c0e61455
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SWISS DOLORCLAST
• Version Model Number: A
• Catalog Number: FT-250#A/002
• Company DUNS: 481233849
• Company Name: E.M.S. Electro Medical Systems S.A.
• 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

Customer Support Contacts

• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353226053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220538

FDA Product Code

• ISA: Massager, Therapeutic, Electric

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: 2022-09-21
• Device Publish Date: 2022-09-13

On-Brand Devices [SWISS DOLORCLAST]

• 07613353077464: Swiss DolorClast
• 07613353000066: Gel bottle
• 07613353000059: Pneumatic foot pedal
• 07613353000042: Applicator Ø15mm
• 07613353000035: Handpiece DolorClast
• 07613353000028: Handpiece kit DolorClast
• 07613353000011: Swiss DolorClast
• 07613353181284: Handpiece DolorClast
• 07613353170264: Gel bottle
• 07613353194895: Cart StackUp
• 04260153472031: Gel bottle
• 07613353226053: DolorClast Radial
• 07613353187101: Compact Cart DolorClast