510(k) DEN210046
- Device
- Quell-FM
- Applicant
- Neurometrix, Inc.
- 510(k) number
- DEN210046
- Product code
- QSQ
- Decision
- Unknown (DENG)
- Decision date
- 2022-05-18
- Date received
- 2021-10-05
- Regulation
- 882.5888
- Classification name
- Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Shai Gozani
- Address
- 4b Gill St. Woburn MA US 01801 01801
FDA Registration Numbers#
- 3011412151
Source Documents#
510(k) summary PDF not indicated by FDA