Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles

Description

This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's.

Scope & Applicability

Regulatory Context

• 21CFR807.87§ 807.87 Information required in a premarket notification submission.

  Each premarket notification submission shall contain the following information:Read full regulation →

• 21CFR807.93§ 807.93 Content and format of a 510(k) statement.

  (a)Read full regulation →

• 21CFR807.92§ 807.92 Content and format of a 510(k) summary.

  (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →

• 21CFR801.109§ 801.109 Prescription devices.

  A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →

• 21CFR890.3860§ 890.3860 Powered wheelchair.

  (a) Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.Read full regulation →

• 21CFR890.3850§ 890.3850 Mechanical wheelchair.

  (a) Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.Read full regulation →

• Medical Devices/Adulterated/Quality System Regulation (QSR)

  iRhythm Technologies, Inc.

  2023-06-06

• Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

  Tenderneeds Fertility LLC

  2020-04-21

• Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
• Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources - Guidance for Industry (Status: Final)
• Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA Reviewers/Staff (Status: Final)
• Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh - Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance (Status: Final)
• Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems : Guidance for Industry (Status: Final)
• Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators - Guidance for Industry (Status: Final)
• Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm) - Guidance for Industry (Status: Final)
• Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement) - Guidance for Industry (Status: Final)