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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 6-253: ISO 10535 Second edition 2006-12-15, hoists for the transfer of disabled persons - requirements and test methods. (General Plastic Surgery/General Hospital)

Date of Standard: 2006. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
(3)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
Devices Affected:
Patient Transfer Devices; both ac-powered and non-ac-powered patient care lifts
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.5500 Lift, Patient, Ac-Powered Class 2 FNG
§880.5510 Lift, Patient, Non-Ac-Powered Class 1 FSA
FDA Technical Contacts:
 Joan Todd
  FDA/CDRH/OSB
  10903 New Hampshire Avenue Building 66, Room 3118
  Silver Spring MD 20993
  301/796-6079
  email: joan.todd@fda.hhs.gov
 Matthew Schwerin
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2216
  Silver Spring MD 20993
  301/563-9114
  email: matthew.schwerin@fda.hhs.gov
 Alan Stevens
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2561
  Silver Spring MD 20993
  301/796-6294
  email: alan.stevens@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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