Fall Guardian FG1BW1-SYS/CS
by Smart Caregiver Corporation
Fall Guardian FG1BW1-SYS/CS is a Class I device made by Smart Caregiver Corporation, listed in FDA GUDID since 19 Jul 2022 (UDI-DI 00812293015186), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00812293015186 | Date19 Jul 2022 | StatusListed |
Official records
- AccessGUDID record 00812293015186
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Fall Guardian
- Generic name
- Bed/chair occupant movement pressure/vibration sensor
- Model / reference
- FG1BW1-SYS/CS
- Primary DI / UDI-DI
- 00812293015186
- FDA product code
- KMI
- GMDN term
- Bed/chair occupant movement pressure/vibration sensor
- Device class
- Class I
- Regulation number
- 880.2400
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KMI (Monitor, Bed Patient).
- FALL-SAFE VEST by Fsm Corp.
- TELETOM by Berchtold Holding GmbH
- VIVATRAK by Wireless Medcare, LLC
- PMD SYSTEM-20 by Datatek, Inc.
- FALL-SAFE MONITOR by Fsm Corp.
- POSEY SITTER by J. T. Posey Co.
- JDM SP2 SENSOR by Jd Monitoring C/O Mackler, Cooper and Gibbs
- AMB-ALERT by MED WAY INC.
- BED-CHECK: II-IFAC by Bed-Check Corp.
- INFORMER PLUS by Microtech Medical, Inc.