True-Trac, Stratus

FDA 510(k) K926316 · Henley Intl.

Substantially Equivalent

510(k) numberK926316

Submission

Device name
True-Trac, Stratus
Applicant
Henley Intl.
Sugar Land, TX, US
Received
December 15, 1992
Decision date
March 24, 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
JFB – Table, Physical Therapy, Multi Function
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5880
Specialty
Physical Medicine

Other 510(k)s with product code JFB

510(k)DeviceApplicantDecision
K250266Ceragem Automatic Thermal Massager (CGM MB-2401)JFB · Traditional Ceragem Co., Ltd.07/11/2025SE
K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)JFB · Traditional Marzzan Lucas Jorge01/31/2025SE
K243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)JFB · Special Ceragem Co., Ltd.01/08/2025SE
K243355Ceragem Automatic Thermal Massager (CGM-MB-1902)JFB · Special Ceragem Co., Ltd.11/27/2024SE
K240168N7-SJFB · Traditional Nuga Medical Co., Ltd.09/12/2024SE
K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702JFB · Traditional Ceragem Co., Ltd.06/17/2022SE
K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702JFB · Traditional Ceragem Co., Ltd.03/18/2021SE
K202113Ceragem Automatic Thermal Massager, Model CGM-MB-1901JFB · Traditional Ceragem Co., Ltd.03/02/2021SE
K153054N5-1JFB · Traditional Nuga Medical Co., Ltd.02/05/2016SE
K140592Ceragem Automatic Thermal MassagerJFB · Traditional Ceragem International, Inc.12/17/2014SE

More from Ceragem International, Inc.

510(k)DeviceDecision
K943449Neurological Diagnostic DevicesGXY · Traditional 11/15/1995SE
K926279Upper Body ExerciserISD · Traditional 05/05/1994SE
K926278Stair ClimberISD · Traditional 05/05/1994SE
K926287Exercise BicycleISD · Traditional 03/22/1994SE
K926314Hydra Fitness Model 311 Total PowerISD · Traditional 03/18/1994SE
K926313Computerized Testing and Exercise SystemsBXB · Traditional 02/04/1994SE
K915864Monotrode Cutaneous ElectrodeGXY · Traditional 07/21/1993SE
K922036Sonopuls 591IMG · Traditional 06/29/1993SE
K920983Sonopuls 590IMI · Traditional 03/09/1993SE
K922020Endomed 582LIH · Traditional 09/22/1992SE

Questions and answers

When was True-Trac, Stratus cleared by the FDA?

True-Trac, Stratus (K926316) received a 510(k) decision of Substantially Equivalent on March 24, 1993, 99 days after the submission was received.

What is the product code of K926316?

The FDA product code is JFB – Table, Physical Therapy, Multi Function, a Class II (moderate risk) device regulated under 21 CFR 890.5880.