Force Sensing Array

FDA 510(k) K924705 · Force Sensing Systems

Substantially Equivalent

510(k) numberK924705

Submission

Device name
Force Sensing Array
Applicant
Force Sensing Systems
Winnipeg, Manitoba, CA
Received
September 17, 1992
Decision date
May 12, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JFC – System, Pressure Measurement, Intermittent
Device class
Class I (low risk)
Regulation
21 CFR 890.1600
Specialty
Physical Medicine

Other 510(k)s with product code JFC

510(k)DeviceApplicantDecision
K925258Dynamic Pressure Monitor 2000M and 2000CJFC · Traditional Pin Dot Products, Inc.03/09/1993SE
K925052Qa Pressure Measurement SystemJFC · Traditional Gabel Medical Instruments, Ltd.03/09/1993SE
K915278CDG Gait Analyses SystemJFC · Traditional Wrm Computers04/07/1992SE
K914776Oxford Pressure Monitor/Talley Pressure MonitorJFC · Traditional Talley Group, Ltd.12/19/1991SE
K913510Mechanical Shape SensorJFC · Traditional Pin Dot Products, Inc.09/23/1991SE
K881284Computerized Orthopaedic Pedotopography MachineJFC · Traditional Nathaniel Gould Diagnostics, Inc.07/21/1988SE
K8821392P-QDA Foot Pressure Systems Real TimeJFC · Traditional Human Performance Technologies, Inc.06/22/1988SE
K861260PedabarographJFC · Traditional Biokinetics, Inc.05/02/1986SE
K831800Texas Interface Pressure Evaluator-TipeJFC · Traditional Tee-Kay Applied Technology08/16/1983SE
K823681Model Icpm & AccessoriesJFC · Traditional Electromedics, Inc.02/23/1983SE

Questions and answers

When was Force Sensing Array cleared by the FDA?

Force Sensing Array (K924705) received a 510(k) decision of Substantially Equivalent on May 12, 1993, 237 days after the submission was received.

What is the product code of K924705?

The FDA product code is JFC – System, Pressure Measurement, Intermittent, a Class I (low risk) device regulated under 21 CFR 890.1600.