Product code PLU
- Device name
- Thermal System For Insomnia
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5700
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset