Dataglove and Movement Analysis System (Mas)

Q: What is the product code of K943929?

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

FDA 510(k) K943929 · Greenleaf Medical Systems, Inc.

Substantially Equivalent

510(k) numberK943929

Submission

Device name: Dataglove and Movement Analysis System (Mas)
Applicant: Greenleaf Medical Systems, Inc.
Palo Alto, CA, US
Received: August 12, 1994
Decision date: May 15, 1995
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

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)	Device	Applicant	Decision
K011827	Ortelius 800KQX · Traditional	Orthoscan , Ltd.	08/28/2001SE
K971079	Interlogics W-Tracker and Wrist Works SoftwareKQX · Traditional	Interlogics, Inc.	07/09/1997SE
K962377	3D-SPINEKQX · Traditional	Skill Technologies, Inc.	09/03/1996SE
K961212	Spinal TouchKQX · Traditional	Fasstech	06/12/1996SE
K954647	InclinometerKQX · Traditional	J-Tech, Inc.	10/30/1995SE
K945630	Large Muscle Strength GaugeKQX · Traditional	J-Tech, Inc.	05/10/1995SE
K943898	Saunders Electronic InclinometerKQX · Traditional	The Saunders Group	11/28/1994SE
K940812	Insight Electronic Alignment IndicatorKQX · Traditional	Andronic Devices, Ltd.	11/21/1994SE
K925225	The Bte Vector; Analysis System for the Low BackKQX · Traditional	Baltimore Therapeutic Equipment Co.	06/27/1994SE
K933063	Isotechnologies Back Tracker and Back Works SoftwaKQX · Traditional	Isotechnologies, Inc.	01/27/1994SE

More from Isotechnologies, Inc.

510(k)	Device	Decision
K935757	Greenleaf Eval System/ Greenleaf SolosystemLBB · Traditional	04/15/1994SE
K893537	Greenleaf Hand Impairment Evaluation SystemLBB · Traditional	10/10/1989SE
K884723	(Dataglove) Hand Impairment Evaluation SystemKQX · Traditional	02/08/1989SE

Questions and answers

When was Dataglove and Movement Analysis System (Mas) cleared by the FDA?

Dataglove and Movement Analysis System (Mas) (K943929) received a 510(k) decision of Substantially Equivalent on May 15, 1995, 276 days after the submission was received.

What is the product code of K943929?

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