Identity
- Trade Name
- Fall Guardian FDA UDI
- Generic Name
- Bed/chair occupant movement pressure/vibration sensor FDA UDI
- Device Name
- Fall Guardian Basic Monitor and chair sensor pad FDA UDI
- Model / Reference
- FG1C45-SYS FDA UDI
- Description
- Fall Guardian Basic Monitor and chair sensor pad FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812293013410 FDA UDI
- FDA Product Code
- KMI FDA UDI
- GMDN Term
- Bed/chair occupant movement pressure/vibration sensor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.2400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Bed/chair occupant movement pressure/vibration sensor
The Fall Guardian is a medical device designed to detect and measure occupant movement related to activities such as sleep, wakefulness, and/or bed/chair exit. It features an electrically-powered electronic sensing pad (pressure- or mechanical vibration-sensing) that can detect occupant respiration and heart rates, and some types function with an alarm/alert/notification system to indicate unattended occupant attempt to vacate bed/chair.
Similar devices
Also classified as Bed/chair occupant movement pressure/vibration sensor.
- CHAIR PAD-CORDED-TIMED-18 MO-10X15-92"C — CURBELL MEDICAL PRODUCTS, INC. · Class I
- SEAT BELT ALARM FOR MONITORS, VELCRO — CURBELL MEDICAL PRODUCTS, INC. · Class I
- Parasol Wireless Patient Fall Prevention System — PARASOL MEDICAL · Class I
- UN MATT PAD-UNI-CONNECT-18MO-10X30-92" — CURBELL MEDICAL PRODUCTS, INC. · Class I
- Dynarex Protech 45-Day Chair Sensor Pad, 10" x 15" — Dynarex Corp. · Class I
- Parasol Patient Fall Prevention System — PARASOL MEDICAL · Class I
- BED PAD, FALL FIGHTER, 1/4 RECPT — Crest Healthcare Supply · Class I
- FALL FIGHTER, CHAIR PAD, 1/4 — Crest Healthcare Supply · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Smart Caregiver Corporation
Sources (1)
- FDA UDI 3afd788f-b44c-4179-8e8e-4edf3e3c3777 33 fields · synced Oct 6, 2026