Pure Tilt

Wheelchair, Mechanical

Proactive Comfort, LLC

The following data is part of a premarket notification filed by Proactive Comfort, Llc with the FDA for Pure Tilt.

Pre-market Notification Details

• Device ID: K152021
• 510k Number: K152021
• Device Name: Pure Tilt
• Classification: Wheelchair, Mechanical
• Applicant: Proactive Comfort, LLC 3901 Centerview Drive, Suite L Chantilly, VA 20151
• Contact: Tracy Augustine
• Correspondent: Ej Smith; Smith Assoicates 1468 Harwell Avenue Crofton, MD 21114
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-21
• Decision Date: 2016-03-31
• Summary: summary