DeviceClearance

Product code NKI— Orthopedic

SONOSENS

Classification name
Goniometer With Electrodes
Device class
Class 2
Regulation
21 CFR 888.1500
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NKI under 21 CFR 888.1500, via openFDA

Market context for product code NKI

FDA has cleared 1 device under product code NKI, all in 2004, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NKI

Recent clearances under product code NKI

Data sourced from openFDA. This site is unofficial and independent of the FDA.