FDA.reportPublic FDA data

Summit Medical

Primary DI
80092237618871
Brand
Summit Medical
Company
COMPASS HEALTH BRANDS CORP.
Model
E1F1515TC2-SM
Device description
Summit Medical PL'd 1.5 x 1.5
Published
2016-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30092237618876PackageGS150In Commercial Distribution
80092237618871PackageGS18In Commercial Distribution
00092237618875PrimaryGS10
01092237618874Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3009223761887630092237618876
8009223761887180092237618871
00092237618875000922376188750922376188750092237618875
01092237618874010922376188741092237618874

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-572-1962CustomerService@compasshealthbrands.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
827221698
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00092237613269Roscoe MedicalLS52662016-10-13
00194346678921Equate73085EQ2026-03-09
00714905117649Fab StimDT30252026-02-06
00714905710024Fab StimDT70252026-02-06
00860163000312CMS DT30292026-02-06
00092237622209SCRIPHESSCO672-0192-CH2026-02-03
00092237622216SCRIPHESSCO672-0193-CH2026-02-03
00092237622339SCRIPHESSCO672-0195-CH2026-02-03
30194346615156Equate 72085EQ2026-01-20
00092237627495Roscoe MedicalO2C6P2026-01-15
00023601130402CarexFGB30400 00002025-12-01
00092237622193SCRIPHESSCO672-0010-CH2025-11-24
00714905710062FabStimE1P3000TC2FS2025-11-18
00092237621967TwinStimDS5002-OTC2025-09-29
00092237902257MicroBlock Antimicrobial Electrode400-877-MIC2020-06-11
00092237902240MicroBlock Antimicrobial Electrode400-872-MIC2019-01-08
00092237902288MicroBlock Antimicrobial Electrode400-852-MIC2020-06-11
00092237902264MicroBlock Antimicrobial Electrode400-879-MIC2020-06-11
00092237902271MicroBlock Antimicrobial Electrode400-881-MIC2020-06-11
00092237611531Roscoe MedicalLS52552016-10-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594795Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-20
08057971594801Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-20
08057971594818Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-20
B195XC813waveguardeemagine Medical Imaging Solutions GmbHGXY2026-03-19
03615220004355Neuronaute IceCap 2 SmallBIOSERENITY MEDICAL DEVICES GROUPGXY2026-03-17
00860008546005Nexalin ADINEXALIN TECHNOLOGYGXY2026-03-16
09342451004772Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-03
00850080988121AUVONUAN HEALTHCARE LIMITEDGXY2026-03-02
09342451003904Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451003980Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451003997Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004000Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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09342451004024Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004031Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004314Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004611Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004628Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004635Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004642Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004659Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004673Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004680Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004697Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004703Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004710Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004727Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004734Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004741Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004758Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02