100692

GUDID 04055207069226

THERAPY SOURCE F10 G10 BLUE for USA only, for use with PiezoWave 2, point-focused, with trigger button, maximum penetration depth 60 mm, maximum pulse repetition rate 12 Hz, intensity levels 1-18 and 0.1-0.9, total energy flux density (EFD) 0.007-0.093 mJ/mm², peak pressure (p+) 2.6-20.7 MPa

Richard Wolf GmbH

Electromechanical orthopaedic extracorporeal shock wave therapy system

• Primary Device ID: 04055207069226
• NIH Device Record Key: 128bf462-7962-47aa-930f-578b2545d07f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 100692
• Catalog Number: 100692
• Company DUNS: 315304071
• Company Name: Richard Wolf GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04055207069226 [Primary]

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: 2026-03-20
• Device Publish Date: 2026-03-12

Devices Manufactured by Richard Wolf GmbH

• 04055207069226 - NA: 2026-03-20THERAPY SOURCE F10 G10 BLUE for USA only, for use with PiezoWave 2, point-focused, with trigger button, maximum penetration depth 60 mm, maximum pulse repetition rate 12 Hz, intensity levels 1-18 and 0.1-0.9, total energy flux density (EFD) 0.007-0.093 mJ/mm², peak pressure (p+) 2.6-20.7 MPa
• 04055207069226 - NA: 2026-03-20 THERAPY SOURCE F10 G10 BLUE for USA only, for use with PiezoWave 2, point-focused, with trigger button, maximum penetration dep
• 04055207069257 - NA: 2026-03-20 GEL PAD ASSORTMENT F10 G10 for use with the PiezoWave 2, penetration depth 10 mm, 20 mm, 30 mm, 40 mm, 50 mm and 60 mm
• 04055207068243 - VERTEBRIS: 2026-02-18 KNOT PUSHER Ø 2.5MM WL 330MM reusable
• 04055207069691 - NA: 2026-02-18 CAGE SLEEVE ID 15MM OD 16 mm, TL 145 mm, reusable
• 04055207069707 - NA: 2026-02-18 CAGE SLEEVE SQUARE ID 15MM OD 16 mm, TL 145 mm, reusable
• 04055207069714 - NA: 2026-02-18 CAGE SLEEVE SQUARE ID 13.6MM OD 14,6 mm, TL 145 mm, reusable
• 04055207069721 - NA: 2026-02-18 CAGE SLEEVE ID 13.6MM OD 14,6 mm, TL 145 mm, reusable
• 04055207069738 - NA: 2026-02-18 DILATOR SQUARE ID 9.5MM OD 14.9MM TL 210 mm, reusable