Smartbrace Electrode

FDA 510(k) K940012 · Medical Devices, Inc.

Substantially Equivalent

510(k) numberK940012

Submission

Device name
Smartbrace Electrode
Applicant
Medical Devices, Inc.
St. Paul, MN, US
Received
January 4, 1994
Decision date
December 5, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GXY – Electrode, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1320
Specialty
Neurology

Other 510(k)s with product code GXY

510(k)DeviceApplicantDecision
K262654Dexus Prosthetic System (MSL2, MSR2)GXY · Special Zhejiang Qiangnao Technology Co.,Ltd08/27/2026SE
K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US)…GXY · Traditional Ambu A/S07/14/2026SE
K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayGXY · Abbreviated Cadwell Industries, Inc.06/26/2026SE
K261522BioWave BioWrapsGXY · Special Biowave Corporation06/03/2026SE
K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)GXY · Traditional Elde Medikal Sanayi ve Ticaret Anonim Sirketi05/08/2026SE
K254183MR Conditional Cup ElectrodesGXY · Traditional Technomed Europe05/07/2026SE
K252439Tutamen Self Adhesive ElectrodesGXY · Traditional Dongguan Tutamen Metalwork Co., Ltd.05/01/2026SE
K253256myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…GXY · Traditional Otto Bock Healthcare Products GmbH04/22/2026SE
K260363Ceribell Brain Monitor HeadbandGXY · Abbreviated Ceribell, Inc.04/03/2026SE
K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)GXY · Special Bionit Labs Srl03/12/2026SE

More from Bionit Labs Srl

510(k)DeviceDecision
K131719Ophthalmoscopes Diagnostic Instrument KitsHLJ · Traditional 10/30/2013SE
K002280Pad Pro Pediatric Electrode, Model Pad Pro 2602MKJ · Traditional 02/05/2001SE
K930084Micro-ArthroscopeHRX · Traditional 09/01/1995SN
K943126ElectroflexGXY · Traditional 12/05/1994SE
K935132Home Microcurrent HMCGZJ · Traditional 03/14/1994SE
K934619FlexmateGZJ · Traditional 02/23/1994SE
K924897Xenon Endoscopic Illuminator, Model XEI-300GCT · Traditional 07/06/1993SE
K930053Video Camera W/ Electronic Shutter Model VCE-10FWF · Traditional 05/17/1993SE
K923914If-Ii (TM), Model 7200IPF · Traditional 11/06/1992SE
K920071Meditron Automatic Electronic Insuff. Model AEI-15GEI · Traditional 07/21/1992SE

Questions and answers

When was Smartbrace Electrode cleared by the FDA?

Smartbrace Electrode (K940012) received a 510(k) decision of Substantially Equivalent on December 5, 1994, 335 days after the submission was received.

What is the product code of K940012?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.