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510(k) K962681

Device
ECOGEL 300 TENS GEL
Applicant
ECO-MED PHARMACEUTICALS, INC.
510(k) number
K962681
Product code
GYB  
Decision
Substantially Equivalent (SESE)
Decision date
1996-10-04
Date received
1996-07-10
Regulation
882.1275
Classification name
Media, Electroconductive
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAUL L HOOEY
Address
6155 Tomken Rd. Unit 13 Mississauga, Ontario CA L4W 1H3 L4W 1H3

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GYB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd.2025-04-08
K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc.2023-09-15
K222770Conductive GelTop-Rank Health Care Co., Ltd.2022-12-13
K221724Conductive GelTone-A-Matic International, Inc.2022-09-23
K212325EEG-acpSomnomedics GmbH2022-06-15
K212326AC Cream - Conductive pasteSpes Medica Srl2021-12-01
K212787GT5 conductive & abrasive gelWuhan Greentek Pty , Ltd.2021-11-08
K200402DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd.2020-11-25
K191975Elefix V Paste for EEG & EMGNihon Kohden Corporation2020-02-07
K192606SAC2 - Electrode CreamSpes Medica Srl2020-01-17
K190050Tech Dots - Adhesive and conductive gelSpes Medica Srl2019-07-19
K161715EndyGelEndymed Medical, Ltd.2017-02-07
K161654NuFACE Gel PrimerCarol Cole Company2016-12-30
K111717ELECTRO-GELElectro-Cap Intl., Inc.2012-01-05
K032239THERA-CREAM, MODEL TCT004Prizm Medical, Inc.2004-07-30

Legacy Summary#

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FDA Review#

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