DeviceClearance

Product code KQX— Orthopedic

(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM

Classification name
Goniometer, Ac-Powered
Device class
Class 1
Regulation
21 CFR 888.1500
Advisory panel
Orthopedic
Total cleared
33
First cleared
Most recent

Market context for product code KQX

FDA has cleared 33 devices under product code KQX between 1981 and 2001, filed by 27 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code KQX

Recent clearances under product code KQX

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