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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 17-11: IEC 60601-2-10 Edition 2.0 2012-06, medical electrical equipment -- part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators. (Neurology)

Date of Standard: 2012. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Powered Muscle Stimulators
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§890.5850 Stimulator, Muscle, Powered Class 2 IPF
§890.5850 Stimulator, Muscle, Powered, Dental Class 2 NUW
§890.5850 Stimulator, Muscle, Powered, For Muscle Conditioning Class 2 NGX
§890.5850 Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning Class 2 NYZ
§890.5850 Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation Class 2 NYY
Relevant Guidance:
Guidance for Industry, FDA Reviewers/Staff and Compliance Guidance Document for Powered Muscle Stimulator 510(k)s. Document issued on: June 9, 1999

For Industry and FDA Staff Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables. Document issued on: November 15, 1999
FDA Technical Contact:
 Michael Hoffmann
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1434
  Silver Spring MD 20993
  301/796-6476
  email: michael.hoffmann@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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