FDA UDI
In Commercial Distribution
🇺🇸 United States
DOOPANG
DI: 08800020403032
·
Model: YPS-301BD
·
Ybrain Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DOOPANG
- Primary DI
- 08800020403032
- Version / Model
- YPS-301BD
- Company Name
- Ybrain Inc.
- Labeler DUNS
- 696467691
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-10
- Public Version
- 1
- Public Version Date
- 2026-03-18
- Public Version Status
- New
- Public Device Record Key
- 15aa0107-0c92-4326-8656-e5817560a675
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | Neurology | 882.5891 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58832 | Migraine-therapy peripheral nerve electrical stimulator | A portable electrically-powered device designed to non-invasively stimulate a peripheral nerve(s) [including vagus nerve] in the neck, trunk or extremity to treat or prevent symptoms of migraine/headaches. It typically consists of a unit with operator controls, user display, and metal skin contact surfaces that enable application of the electrical signal intended to provide a localized oscillating electric field; it may be used in conjunction with a smartphone. The device is typically used with conductive gel and may be operated by a patient or healthcare provider in the home and healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800020403032 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232749 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 104 Degrees Fahrenheit