Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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12-266
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Standard | |
IEC 61689 Edition 3.0 2013-02 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz |
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Scope/AbstractThis International Standard is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous wave ultrasound in the frequency range 0,5 MHz to 5 MHz.
This standard only relates to ultrasonic physiotherapy equipment employing a single plane non-focusing circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. |
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Extent of Recognition
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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. |
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |