Milieve (YPS-301BD)
FDA 510(k) clearance K233751 · decided 2024-06-03
Clearance details
- K-number
- K233751
- Device name
- Milieve (YPS-301BD)
- Applicant
- Soterix Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-22
- Decision date
- 2024-06-03
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- PCC
- Device class
- 2
- Regulation number
- 882.5891
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Woodbridge, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Relivion (K212106) | Neurolief , Ltd. | 2021-08-02 |
| Elexir (K211380) | Nu Eyne Co., Ltd. | 2021-07-30 |
| Migraine Tens Digital Pain Reliever (K210364) | Shenzhen Dongdixin Technology Co., Ltd. | 2021-06-17 |
| Relivion (K203419) | Neurolief , Ltd. | 2021-02-16 |
| Cefaly Dual (K201895) | Cefaly Technology | 2020-09-29 |
| ALLIVE (K192773) | Nu Eyne Co., Ltd. | 2019-12-06 |
Recalls involving this device
No recalls on record reference this clearance.