Model: 104
Catalog: SYS-104-002-R
DI: 07290110538286
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Deep TMS 104 system with H7 - refurbished
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bbbbf2fc-aafb-4814-bb0e-70fc2b315878
Distribution Status:
In Commercial Distribution
DUNS Number:
531873441
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07290110538286
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61124
Name: Magnetic neural stimulation system
Definition:
An assembly of electrically-powered devices intended for the treatment and/or diagnosis of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools.
FDA Product Codes
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
OBP
Transcranial Magnetic Stimulator
Premarket Submissions
Item #1 - Submission Number:
K183303
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K220819
Item #2 - Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Kilogram
Item #1 - Size - @attributes - Value:
161
Item #1 - Size Type:
Weight
Item #2 - Size - @attributes - Unit:
Centimeter
Item #2 - Size - @attributes - Value:
205
Item #2 - Size Type:
Height
Item #3 - Size - @attributes - Unit:
Centimeter
Item #3 - Size - @attributes - Value:
68
Item #3 - Size Type:
Length
Item #4 - Size - @attributes - Unit:
Centimeter
Item #4 - Size - @attributes - Value:
68.8
Item #4 - Size Type:
Width
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
-20
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
60
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
10
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
85
Item #2 - Storage Handling Type:
Storage Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling Low - @attributes - Value:
50
Item #3 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling High - @attributes - Value:
106
Item #3 - Storage Handling Type:
Storage Environment Atmospheric Pressure