FDA.reportPublic FDA data

SAVI Dual(TM) Migraine Therapy

Primary DI
00816140020132
Brand
SAVI Dual(TM) Migraine Therapy
Company
ENEURA, INC.,
Model
DWG-0601
Device description
Patient use, Non-invasive, Central Neuromodulation Smart Device
Published
2022-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine HeadacheNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161663000sTMS miniEneura, Inc.2016-08-23OKP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816140020132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816140020132008161400201328161400201320816140020132

GMDN Terms#

Term, Definition table
TermDefinition
Home-use magnetic neural stimulatorA rechargeable battery-powered device intended to be used for the treatment of pain associated with migraine headache (with or without aura) through noninvasive transcranial magnetic stimulation (TMS) of the brain. It is a hand-held unit intended to be placed at the base of the skull at the earliest onset of symptoms of a migraine headache, to reduce or stop the effects of migraine headache, through generation of a single pulse magnetic field. It is typically programmed to deliver treatment in accordance with a specific patient prescription and is intended to be used in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013665656
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816140020002SpringTMSDWG-0055-USDWG-0055-US2016-08-22
00816140020019SpringTMSDWG-0055-UKDWG-0055-UK2016-08-22
00816140020040SpringTMSDWG-0050DWG-00502016-08-22
00816140020071sTMS miniDWG-0501-USDWG-0501-US2017-02-01
00816140020088sTMS miniDWG-0501-UKDWG-0501-UK2017-02-01
00816140020095sTMS miniDWG-0505DWG-05052017-02-01
00816140020101SpringTMSDWG-0096DWG-00962016-08-22
00816140020118sTMS miniDWG-0501-AUDWG-0501-AU2018-03-22
00816140020125sTMS miniDWG-0501-SGDWG-0501-SG2018-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816140020118sTMS miniENEURA, INC.,OKP2018-03-22
00816140020125sTMS miniENEURA, INC.,OKP2018-03-22
00816140020071sTMS miniENEURA, INC.,OKP2017-02-01
00816140020088sTMS miniENEURA, INC.,OKP2017-02-01
00816140020095sTMS miniENEURA, INC.,OKP2017-02-01
00816140020002SpringTMSENEURA, INC.,OKP2016-08-22
00816140020019SpringTMSENEURA, INC.,OKP2016-08-22
00816140020040SpringTMSENEURA, INC.,OKP2016-08-22
00816140020101SpringTMSENEURA, INC.,OKP2016-08-22