510(k) DEN200046
- Device
- Neurolutions Upper Extremity Rehabilitation System
- Applicant
- Neurolutions, Inc.
- 510(k) number
- DEN200046
- Product code
- QOL
- Decision
- Unknown (DENG)
- Decision date
- 2021-04-23
- Date received
- 2020-07-23
- Regulation
- 890.5420
- Classification name
- Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Kern J. Bhugra
- Address
- 1101 Pacific Ave., Suite 300 Santa Cruz CA US 95060 95060
FDA Registration Numbers
- 3030779215
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850005539025 | Neurolutions Ipsihand Upper Extremity Rehabilitation System | Neurolutions, Inc | 2022-09-12 |
| 00850005539018 | Neurolutions Ipsihand Upper Extremity Rehabilitation System | Neurolutions, Inc | 2022-09-12 |