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Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 12-276: IEC TS 62462 First edition 2007-05, ultrasonics - output test - guide for the maintenance of ultrasound physiotherapy systems. (Radiology)

Date of Standard: 2007. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF COMPLIANCE (OC)
(2)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
(3)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(4)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
(5)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Ultrasonic diathermy (physiotherapy) devices for use in applying therapeutic deep heat for selected medical conditions such as relief of pain, muscle spasms, and joint contractures. Pulsed, CW, Stationary, Movable, Single, non-focused Transducer
Processes Affected:
510(k)
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§890.5300 Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Class 3 LXF
§890.5300 Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Class 2 PFW
§890.5300 Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Class 2 IMI
Relevant Guidance:
CFR Sec. 1050.10 Ultrasonic therapy products
FDA Technical Contact:
 Bruce Herman
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2204
  Silver Spring MD 20903
  301/796-2521
  email: bruce.herman@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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