Product Classification

• Device: antimicrobial blood pressure cuff
• Regulation Description: Blood pressure cuff.
• Definition: Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. 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.
• Physical State: The device is a typically a textile enfolded over an inflatable bladder.
• Technical Method: The blood pressure cuff wraps around the subject's arm or wrist and the bladder is inflated. The pressure from the bladder occludes the artery. When the pressure is slowly released, the Korotkoff sounds or oscillometric wave form produced is interpreted as sytolic and diastolic blood pressures.
• Target Area: The cuff is placed either over the upper arm, wrist, or thigh.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: OED
• Premarket Review: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: 510(k)
• Regulation Number: 870.1120
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc