510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033193Substantially Equivalent

Sonosens

Friendly Sensors AG, Washington DC / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033193 is the FDA 510(k) clearance record for SONOSENS, a class II device, cleared for Friendly Sensors AG on under FDA product code NKI (Goniometer With Electrodes). FDA's definition for product code NKI reads: "A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses...". FDA records list one 510(k) clearance for Friendly Sensors AG. As of , FDA records show no recalls naming K033193.

Clearance record

Decision date
Received
(113 days to decision)
Product code
NKI Goniometer With Electrodes
Regulation
21 CFR 888.1500
Device class
Class II
Review panel
Orthopedic
Applicant
Friendly Sensors AG 719 A St. NE, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NKI

Trailing 12 months

FDA records hold no clearances under product code NKI in the trailing twelve months.

FDA records show no clearances under product code NKI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NKI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260