Product Classification

• Device: blood pressure cuff
• Regulation Description: Blood pressure cuff.
• Definition: A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder.The cuff is used to determine a subject's blood pressure.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DXQ
• Submission Type: 510(k)
• Regulation Number: 870.1120
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/( Manual, electronic or automated sphygmomanometers
• AAMI/ANSI/ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
• ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

Guidance Document

• Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; Final

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.