sTMS mini DWG-0501-AU

GUDID 00816140020118

Transcranial Magnetic Stimulator Device

ENEURA, INC.,

Home-use magnetic neural stimulator Home-use magnetic neural stimulator Home-use magnetic neural stimulator
Primary Device ID00816140020118
NIH Device Record Key684c245c-e37f-4bcd-bae5-482ce01ad3e2
Commercial Distribution StatusIn Commercial Distribution
Brand NamesTMS mini
Version Model NumberDWG-0501-AU
Catalog NumberDWG-0501-AU
Company DUNS013665656
Company NameENEURA, INC.,
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(408)245-6400
EmailCustomercare@eneura.com
Phone+1(408)245-6400
EmailCustomercare@eneura.com
Phone+1(408)245-6400
EmailCustomercare@eneura.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100816140020118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OKPTranscranial magnetic stimulator for the treatment of migraine headache

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-22

On-Brand Devices [sTMS mini]

00816140020125Transcranial Magnetic Stimulator Device
00816140020118Transcranial Magnetic Stimulator Device
00816140020095Transcranial Magnetic Stimulator AC Adapter
00816140020088Transcranial Magnetic Stimulator Device
00816140020071Transcranial Magnetic Stimulator Device

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.