DOOPANG
- Primary DI
- 08800020403032
- Brand
- DOOPANG
- Company
- Ybrain Inc.
- Model
- YPS-301BD
- Published
- 2026-03-10
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | Neurology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K232749 | 000 | DOOPANG | Ybrain, Inc. | 2024-06-11 | PCC |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08800020403032 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08800020403032 | 08800020403032 | 8800020403032 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 41 Degrees Fahrenheit | 104 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 696467691
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices Sharing Product Codes