REAL System Bands BND-A
REAL System Bands BND-A is a Class II device made by Penumbra, Inc., cleared under FDA 510(k) K183296 on 18 Mar 2019 and listed in FDA GUDID since 17 Jun 2020 (UDI-DI 00815948022416), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00815948022416 | Date17 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183296 | Date18 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 00815948022416
- FDA 510(k) database K183296
Across registries
- FDA 510(k) K183296 decided 18 Mar 2019 Active
- FDA GUDID UDI-DI 00815948022416 listed 17 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K183296
- Listed FDA GUDID 00815948022416
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- REAL System Bands
- Generic name
- Virtual-display rehabilitation system, non-supportive, clinical
- Model / reference
- BND-A
- Primary DI / UDI-DI
- 00815948022416
- 510(k) Number
- FDA product code
- ISD
- GMDN term
- Virtual-display rehabilitation system, non-supportive, clinical
- Device class
- Class II
- Regulation number
- 890.5360
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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