Kronamax Kube

FDA 510(k) K893903 · Physicians Digital Co.

Substantially Equivalent

510(k) numberK893903

Submission

Device name
Kronamax Kube
Applicant
Physicians Digital Co.
Richmond, CA, US
Received
May 30, 1989
Decision date
November 29, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KQX – Goniometer, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 888.1500
Specialty
Orthopedic

Other 510(k)s with product code KQX

510(k)DeviceApplicantDecision
K011827Ortelius 800KQX · Traditional Orthoscan , Ltd.08/28/2001SE
K971079Interlogics W-Tracker and Wrist Works SoftwareKQX · Traditional Interlogics, Inc.07/09/1997SE
K9623773D-SPINEKQX · Traditional Skill Technologies, Inc.09/03/1996SE
K961212Spinal TouchKQX · Traditional Fasstech06/12/1996SE
K954647InclinometerKQX · Traditional J-Tech, Inc.10/30/1995SE
K943929Dataglove and Movement Analysis System (Mas)KQX · Traditional Greenleaf Medical Systems, Inc.05/15/1995SE
K945630Large Muscle Strength GaugeKQX · Traditional J-Tech, Inc.05/10/1995SE
K943898Saunders Electronic InclinometerKQX · Traditional The Saunders Group11/28/1994SE
K940812Insight Electronic Alignment IndicatorKQX · Traditional Andronic Devices, Ltd.11/21/1994SE
K925225The Bte Vector; Analysis System for the Low BackKQX · Traditional Baltimore Therapeutic Equipment Co.06/27/1994SE

More from Baltimore Therapeutic Equipment Co.

510(k)DeviceDecision
K902219Kronamax Human Performance LabIKK · Traditional 07/25/1990SE

Questions and answers

When was Kronamax Kube cleared by the FDA?

Kronamax Kube (K893903) received a 510(k) decision of Substantially Equivalent on November 29, 1989, 183 days after the submission was received.

What is the product code of K893903?

The FDA product code is KQX – Goniometer, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 888.1500.