REAL Sensor Bands BND
REAL Sensor Bands BND 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 00815948021389), 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 | Number00815948021389 | Date17 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183296 | Date18 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 00815948021389
- FDA 510(k) database K183296
Across registries
- FDA 510(k) K183296 decided 18 Mar 2019 Active
- FDA GUDID UDI-DI 00815948021389 listed 17 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K183296
- Listed FDA GUDID 00815948021389
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- REAL Sensor Bands
- Generic name
- Virtual-display rehabilitation system, non-supportive, clinical
- Model / reference
- BND
- Primary DI / UDI-DI
- 00815948021389
- 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
Similar devices
Other devices filed under FDA product code ISD (Exerciser, Measuring).
- ACTITRAINER by ActiGraph
- AUTORANGE by Tri W-G, Inc.
- MULTI JOINT WEIGHT SYSTEM MODEL #940-100 by Biodan Medical Systems, Ltd.
- CABLE COLUMN WEIGHT SYSTEM MODEL #940-200 by Biodan Medical Systems, Ltd.
- FINGER MUSCLE TESTER by Bel-Art Products
- GRAVITRON UPPER BODY SYSTEM EXERCISER by Tri-Tech, Inc.
- QUINTON MEDTRACK CR PLUS TREADMILL by Quinton, Inc.
- APPLIDYN by Grandcor Medical Systems
- STRESS TABLE/ERGOMETER SYSTEM by Victoreen, Inc.
- AEROBITRON 1 by Stanford Scientific, Inc.