DEVICE: spECTrum (00861539000127)
Device Identifier (DI) Information
spECTrum
4000DQ
In Commercial Distribution
MECTA CORPORATION
4000DQ
In Commercial Distribution
MECTA CORPORATION
100 Joule ECT Device with 4 Parameter Setting Controls
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
11484 | Electroconvulsive therapy system |
An 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GXC | Device, Electroconvulsive Therapy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K965070 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
548da6d9-d042-4c33-bbd4-f0c5cccc57fe
July 06, 2018
3
September 24, 2014
July 06, 2018
3
September 24, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(503) 612-6780
info@mectacorp.com
info@mectacorp.com