FDA Device Info: Records for welloStationX

FDA Device Info: Records for welloStationX

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Content: Facility Inspection Records for FDA registration and/or Medical Device Approval 2. Medical Device Approval Records, including PMAs, 510Ks, and De Novo Classifications

Company Name: Wello

Location: Addison, Texas

Device Name: welloStationX

Requested: 2021

  • 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.

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