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De Novo DEN210046
- Device
- Quell-FM
- Contact
- shai gozani
- De Novo number
- DEN210046
- Product code
- QSQ
- Regulation
- 882.5888
- Classification name
- transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms
- Decision
- granted (DENG)
- Decision date
- 2022-05-18
- Date received
- 2021-10-05
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QSQ
- Device name
- Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5888
- Implant
- N
- Life sustain/support
- N