Recognized Consensus Standards

Recognition List Number: 021 Publication Date: 03/18/2009 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 17-5: IEC 60601-2-10 1987/Amendment 1 2001, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators. (Neurology)

Date of Standard: 1987. 

Address of Standards 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:

  Laurence Coyne

  FDA/CDRH/ODE

  10903 New Hampshire Avenue Building 66, Room 1526

  Silver Spring MD 20993

  301/796-5650

  Email: laurence.coyne@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