SigmaStim Sigma

Basic Information

• Brand Name: SigmaStim Sigma
• Primary DI: 00850045508012
• Version / Model: 9438-5001
• Company Name: SIGMASTIM DOMESTIC, LLC
• Labeler DUNS: 111226730
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-24
• Public Version: 1
• Public Version Date: 2025-02-03
• Public Version Status: New
• Public Device Record Key: 314fc567-1657-48a6-a87e-e2964ca61829

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QGH	Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder	Neurology	882.5940	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850045508012	GS1

Premarket Submissions

Submission Number	Supplement Number
K192834	000