SOURCE RECORD / S0201
FDA De Novo DEN200046 — Neurolutions Upper Extremity Rehabilitation System
FDA De Novo DEN200046 — Neurolutions Upper Extremity Rehabilitation System
- Authors or organization
- U.S. Food and Drug Administration
- Published date
- 2021-04-23
- Source type
- regulatory_database_record
- Technology route
- non-invasive EEG-driven upper-extremity powered exerciser
- Function or setting
- stroke rehabilitation regulation
- Rights status
- manual_review
Legacy aliases
EXO-S066 · EXO-S377
Related topics
- BCI 最优方案
- AI×BCI 与外骨骼
Evidence summary
Evidence: U.S. Class II classification and De Novo decision for an EEG-driven rehabilitation device. Key figures: DEN200046; product code QOL; Class II; 21 CFR 890.5420; decision date 2021-04-23; implant flag N. Limitations: U.S. regulatory fact only; not Chinese approval, comparative effectiveness, current sales status, or evidence that all BCI rehabilitation products share this pathway; openFDA warns its API data are unvalidated.
Key figures
DEN200046; product code QOL; Class II; 21 CFR 890.5420; decision date 2021-04-23; implant flag N
Limitations
U.S. regulatory fact only; not Chinese approval, comparative effectiveness, current sales status, or evidence that all BCI rehabilitation products share this pathway; openFDA warns its API data are unvalidated
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