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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 12-313
IEC  TS 62462 Edition 2.0 2017-07
Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems
This document, which is a Technical Specification, describes methods meant to assist users of ultrasound physiotherapy systems in checking the performance of such systems. It is applicable primarily to physiotherapists, general medical practitioners, chiropractors, osteopaths, beauty therapists, sports professionals, biomedical engineers, medical physicists, medical device service agents, commercial testers, test houses or manufacturers. Typical ultrasound physiotherapy systems operate in the range from 0,5 MHz to 5 MHz. Long-wave ultrasound therapy machines operating in the frequency range 30 kHz to 0,5 MHz are not covered by this document.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.5300 Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Class 2 PFW
§890.5300 Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Class 3 LXF
§890.5300 Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Class 2 IMI
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Subha Maruvada
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.