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

Goniometer With Electrodes

21 CFR 888.1500 / Orthopedic
FDA source (opens on fda.gov)

NKI is the FDA product code for Goniometer With Electrodes, a class II device type, regulated under 21 CFR 888.1500. FDA's definition for this code 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 transcutaneous adhesive electrode lead wires and patient cables to transmit and record...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NKI
Device name
Goniometer With Electrodes
FDA definition
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 transcutaneous adhesive electrode lead wires and patient cables to transmit and record patient data.
Regulation
21 CFR 888.1500
Device class
Class II
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NKI

By decision year
1 clearance under product code NKI with a decision year between 2004 and 2004, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NKI by decision year
YearClearances
20041

Applicants with the most clearances

Product code NKI
Applicants holding the most 510(k) clearances under product code NKI
ApplicantClearances
Friendly Sensors AG1

Companies listing this code with FDA

Companies whose registered establishments list this code