Product Classification

• Device: ultrasonic diathermy for use in applying therapeutic deep heat
• Regulation Description: Ultrasonic diathermy.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: IMI
• Premarket Review: Neuromodulation and Rehabilitation Devices (DHT5B); Neuromodulation and Rehabilitation Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 890.5300
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 12-275 IEC 61161 Edition 3.0 2013-01
  Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
• 12-313 IEC TS 62462 Edition 2.0 2017-07
  Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc