MamaLift Plus
FDA 510(k) clearance K223515 · decided 2024-04-22
Clearance details
- K-number
- K223515
- Device name
- MamaLift Plus
- Applicant
- Curio Digital Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-22
- Decision date
- 2024-04-22
- Days to decision
- 517 days
- Clearance type
- Traditional
- Product code
- SAP
- Device class
- 2
- Regulation number
- 882.5801
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Motivista (CT-155) (K254038) | Click Therapeutics, Inc. | 2026-07-30 |
| Rejoyn (K231209) | Otsuka America Pharmaceutical, Inc. | 2024-03-30 |
Recalls involving this device
No recalls on record reference this clearance.