Allive
Catalogue number ALLIVE01, listed by NU Eyne Co., Ltd., South Korea, under Stimulator, Nerve, Electrical, Transcutaneous, For Migraine. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| WAT Medical Technology Inc. | Ningbo | Zhejiang | Repacker / relabeller | 4 |
Record
| Listed by | NU Eyne Co., Ltd., South Korea |
|---|---|
| FDA product code | PCC |
| Device type | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5891 |
| Establishment | Manufacturer |
| 510(k) | K192773 |
| Record published | 2021-03-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 25 to 85 % RH; Storage environment temperature -5 to 45 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ALLIVE01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cefaly® | Cefaly Technology Sprl | 14 |
| HeadaTerm | WAT Medical Technology Inc. | 3 |
| Relivion | Neurolief Inc. | 2 |
| Elexir | NU Eyne Co., Ltd. | 1 |
| Relivion MG App | Neurolief Inc. | 1 |
| Tens 7000 | Drive DeVilbiss Healthcare | 1 |
| Doopang | Ybrain Inc. | 1 |
| Relivion MG PMI Physician Interface | Neurolief Inc. | 1 |
| Enso | Hinge Health Inc. | 1 |
| AccuRelief | Drive DeVilbiss Healthcare | 1 |
| Elexir 2.0 | NU Eyne Co., Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242719 | 2024-11-06 |
| K211380 | 2021-07-30 |
| K192773 | 2019-12-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.