FDA UDI
In Commercial Distribution
🇺🇸 United States
SAVI Dual(TM) Migraine Therapy
DI: 00816140020132
·
Model: DWG-0601
·
ENEURA, INC.,
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SAVI Dual(TM) Migraine Therapy
- Primary DI
- 00816140020132
- Version / Model
- DWG-0601
- Company Name
- ENEURA, INC.,
- Labeler DUNS
- 013665656
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-18
- Public Version
- 1
- Public Version Date
- 2022-08-26
- Public Version Status
- New
- Public Device Record Key
- 6a3ac9d4-b013-4b73-82cf-4b52d4bbd96a
Device Description
Patient use, Non-invasive, Central Neuromodulation Smart Device
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| OKP | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache | Neurology | 882.5808 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62219 | Home-use magnetic neural stimulator | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816140020132 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161663 | 000 |