PLU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Thermal System For Insomnia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5700
- Medical specialty
- Neurology
- FDA definition
- A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Cereve Sleep System (DEN140032) | Cereve, Inc. | 2016-05-13 |
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