12 Lead Glove

FDA 510(k) K100315 · I Needmd, Inc.

Substantially Equivalent

510(k) numberK100315

Submission

Device name
12 Lead Glove
Applicant
I Needmd, Inc.
New York, NY, US
Received
February 4, 2010
Decision date
April 23, 2010
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement 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

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K171244PhysiotraceDRX · Traditional Nimbleheart, Inc.08/23/2017SE
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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
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 12 Lead Glove cleared by the FDA?

12 Lead Glove (K100315) received a 510(k) decision of Substantially Equivalent on April 23, 2010, 78 days after the submission was received.

What is the product code of K100315?

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