Physiotrace

FDA 510(k) K171244 · Nimbleheart, Inc.

Substantially Equivalent

510(k) numberK171244

Submission

Device name
Physiotrace
Applicant
Nimbleheart, Inc.
Campbell, CA, US
Received
April 28, 2017
Decision date
August 23, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRX – Electrode, Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2360
Specialty
Cardiovascular

Other 510(k)s with product code DRX

510(k)DeviceApplicantDecision
K140096Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeDRX · Traditional Hmicro, Inc.07/24/2014SE
K123658Biomodule 3-M1DRX · Traditional Zephyr Technology Corporation04/24/2013SE
K101576Centerridge Diagnostic ECG Electrode, Centerridge Monitoring ECG ElectrodesDRX · Traditional Team Innovations, Inc.07/22/2010SE
K101685Ip-SetDRX · Traditional Integral Process Sas07/01/2010SE
K100129Ambu Blue Sensor Neo, Ambu Blue Sensor Neo XDRX · Abbreviated Ambu A/S06/11/2010SE
K093327Intco Tab ElectrodeDRX · Abbreviated Shanghai Intco Electrode Manufacturing Co., Ltd.05/10/2010SE
K10031512 Lead GloveDRX · Special I Needmd, Inc.04/23/2010SE
K092744Neonatal ECG Electrode, M203KENDRX · Traditional R & D Medical Products, Inc.12/10/2009SE
K092389Disposal ECG Electrodes, Model EasyrodeDRX · Traditional Suzuken Co., Ltd.10/13/2009SE
K090496Qwiklead Reusable Electrocardiograph Electrode PatchDRX · Traditional Cardiac Lead Technologies, Inc.09/01/2009SE

Questions and answers

When was Physiotrace cleared by the FDA?

Physiotrace (K171244) received a 510(k) decision of Substantially Equivalent on August 23, 2017, 117 days after the submission was received.

What is the product code of K171244?

The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.