spECTrum

Primary DI
00861539000103
Brand
spECTrum
Company
MECTA CORPORATION
Model
5000DQ
Device description
100 Joule ECT Device with 4 Parameter Setting Controls and Patient Monitoring
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXCDevice, Electroconvulsive Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXCDevice, Electroconvulsive TherapyNeurology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K965070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K965070000SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp.1997-03-06QGH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861539000103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861539000103008615390001038615390001030861539000103

GMDN Terms#

Term, Definition table
TermDefinition
Electroconvulsive therapy systemAn assembly of mains electricity (AC-powered) devices designed to apply strong electrical stimuli (electric shocks) to a patient's brain to induce convulsions (fit or grand mal seizure of the brain) and loss of consciousness, typically to treat major depression, schizophrenia, or mania. The stimuli are applied through electrodes placed on the unshaved scalp or on the bare skin over the temples; they are not usually targeted toward specific areas of the brain. The system typically consists of an operator's console with controls, displays and printers, and electrodes; it may also include monitors (e.g., electrocardiograph, electroencephalograph) to display vital signs during treatment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(503) 612-6780info@mectacorp.com

Regulatory Flags#

DUNS number
037079324
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861539000110spECTrum5000DM2014-09-24
00861539000127spECTrum4000DQ2014-09-24
00861539000134spECTrum4000DM2014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007003Thymatron IVSOMATICS, LLCGXC2018-08-23
00607915110758Surgical Ratchet ClipAPPLIED MEDICAL RESOURCES CORPORATIONGXC2016-09-24
10607915110755Surgical Ratchet ClipAPPLIED MEDICAL RESOURCES CORPORATIONGXC2016-09-24
00861539000110spECTrumMECTA CORPORATIONGXC2014-09-24
00861539000127spECTrumMECTA CORPORATIONGXC2014-09-24
00861539000134spECTrumMECTA CORPORATIONGXC2014-09-24