Interlogics W-Tracker and Wrist Works Software

FDA 510(k) K971079 · Interlogics, Inc.

Substantially Equivalent

510(k) numberK971079

Submission

Device name
Interlogics W-Tracker and Wrist Works Software
Applicant
Interlogics, Inc.
Hillsborough, NC, US
Received
March 25, 1997
Decision date
July 9, 1997
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

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K011827Ortelius 800KQX · Traditional Orthoscan , Ltd.08/28/2001SE
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
K933063Isotechnologies Back Tracker and Back Works SoftwaKQX · Traditional Isotechnologies, Inc.01/27/1994SE

Questions and answers

When was Interlogics W-Tracker and Wrist Works Software cleared by the FDA?

Interlogics W-Tracker and Wrist Works Software (K971079) received a 510(k) decision of Substantially Equivalent on July 9, 1997, 106 days after the submission was received.

What is the product code of K971079?

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