FDA 510(k), K152021, Pure Tilt

FDA 510(k), K152021, Pure Tilt

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K152021
Device Name: Pure Tilt
Manufacturer: Tracy Augustine
Device Classification Name: Wheelchair, Mechanical
Regulation Number: IOR
Classification Product Code: KXA
Date Received: 07/21/2015
Decision Date: 03/31/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

View full details