Product Classification

• Device: stationary ultrasonic diathermy device for use in applying therapeutic deep heat
• Regulation Description: Ultrasonic diathermy.
• Definition: Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
• Physical State: Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
• Technical Method: The device uses ultrasonic energy to produce deep heat within the body.
• Target Area: To be applied over body areas such as the shoulder and knee; however, the device should not be applied directly over bone that is near the skin surface.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: PFW
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neuromodulation and Physical Medicine 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

Guidance Document

• Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices - Guidance for Industry and Food and Drug Administration Staff

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