POP
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cranial Motion Measurement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1630
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
- FDA definition
- A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.
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| Record | Firm | Date |
|---|---|---|
| BrainPulse 1100 (K170926) | Jan Medical, Inc. | 2017-04-28 |
| Nautilus BrainPulse 1000 (DEN140040) | Jan Medical, Inc. | 2016-08-01 |
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Every clearance here is in the API, with alerts when new ones post.