PLU — Thermal System For Insomnia Class II
FDA product code PLU covers "Thermal System For Insomnia", a Class II medical device regulated under 21 CFR 882.5700. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PLU
- Device Class
- Class II
- Regulation Number
- 882.5700
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN140032 | cereve | Cereve Sleep System | May 13, 2016 |