Product code

KQW: Goniometer, nonpowered

FDA product code · Class I · Neurology

Key facts

Product code KQW
Device Goniometer, nonpowered
Device class Class I
Regulation number 888.1520
Review panel Neurology
Medical specialty Orthopedic
Submission type 510(K) Exempt
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No

At a glance

  • 10–99 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 100–999 UDI devices (GUDID)
  • 1–9 MAUDE adverse event reports
  • None Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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