Product Classification

• Device: stimulator, electrical, non-implantable, for incontinence
• Regulation Description: Nonimplanted electrical continence device.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: KPI
• Premarket Review: Reproductive, Gynecology and Urology Devices (DHT3B); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: 510(k)
• Regulation Number: 876.5320
• 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

Guidance Document

• Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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