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Sign in to claim this brandSmart Caregiver Corporation
US
Last updated May 23, 2026
What Smart Caregiver Corporation makes
Smart Caregiver Corporation manufactures sensor-based systems for patient safety and caregiver support, including pressure and vibration sensors for beds and chairs, nurse call alarms, and remote controls for patient monitors. Their portfolio also includes fixed call buttons, fall detection sensors for ambulatory patients, and radio-frequency identification readers for asset tracking. The company produces devices under the brand names *Smart Caregiver* and *Fall Guardian*, designed to monitor occupant movement, alert staff to emergencies, and enhance mobility tracking in healthcare settings.
All devices from Smart Caregiver Corporation fall under Class I regulatory classification in the U.S. and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable FDA requirements for medical device registration and compliance.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Smart Caregiver Corporation manufacture?
Smart Caregiver Corporation specializes in sensor-based systems for patient safety and caregiver support. Their devices include bed and chair occupant movement sensors (detecting pressure or vibration), nurse call alarms, remote controls for patient monitors, fixed call buttons, fall detection sensors for ambulatory patients, and RFID readers for tracking assets. These solutions are designed to enhance monitoring, alert staff to emergencies, and improve mobility tracking in healthcare environments.
Where is Smart Caregiver Corporation based, and how does that affect its devices?
Smart Caregiver Corporation is headquartered in the United States, where it develops and manufactures its devices. Since the company operates within the U.S., its products must comply with FDA regulations, including registration and listing requirements. This includes maintaining entries in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory transparency for its Class I devices.
Which regulatory registries or databases list Smart Caregiver Corporation’s devices?
Smart Caregiver Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling better tracking, compliance, and transparency in the healthcare supply chain. This listing is mandatory for Class I devices in the U.S. to ensure they meet regulatory standards.
How are Smart Caregiver Corporation’s devices classified under U.S. regulations?
All devices manufactured by Smart Caregiver Corporation fall under Class I regulatory classification in the U.S. This classification applies to devices posing minimal risk to patients and users, such as sensors, alarms, and basic monitoring systems. Class I devices typically require general controls (e.g., good manufacturing practices) but may not need pre-market approval, though they must still comply with FDA registration and UDI listing requirements.
What are the primary brand names associated with Smart Caregiver Corporation’s devices?
Smart Caregiver Corporation’s devices are marketed under two main brand names: *Smart Caregiver* and *Fall Guardian*. The *Smart Caregiver* brand covers a range of sensor-based solutions for patient monitoring and caregiver support, while *Fall Guardian* focuses on ambulatory fall detection systems. Both brands align with the company’s focus on enhancing safety and operational efficiency in healthcare settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 012082397
Catalogue (511)
Page 9 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Smart Caregiver | 433S2BR1FM5EC-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | 433SBS1EC-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | 433-CMU-60 | FDA UDI | Class I | Active |
| Smart Caregiver | RP-TL-2700 | FDA UDI | Class I | Active |
| Fall Guardian | FG2B90R-SYS/CS | FDA UDI | Class I | Active |
| Smart Caregiver | GC-01 | FDA UDI | Class I | Active |
| Smart Caregiver | RP-BBR1-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | 433-NC | FDA UDI | Class I | Active |
| Smart Caregiver | WEBR1-SYS | FDA UDI | Class I | Active |
| Fall Guardian | FG1C90-SYS/CS | FDA UDI | Class I | Active |
| Smart Caregiver | RP-WPC1-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | NCLA-12 | FDA UDI | Class I | Active |
| Smart Caregiver | DVBR1-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | 433MS-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | PB-06 | FDA UDI | Class I | Active |
| Smart Caregiver | SBR1-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | ELM1-SYS | FDA UDI | Class I | Active |
| Fall Guardian | FG1C1-SYS/CS | FDA UDI | Class I | Active |
| Smart Caregiver | VS-01 | FDA UDI | Class I | Active |
| Smart Caregiver | BPS-01 | FDA UDI | Class I | Active |
| Smart Caregiver | PB-05 | FDA UDI | Class I | Active |
| Smart Caregiver | FM-07C | FDA UDI | Class I | Active |
| Smart Caregiver | BPP-90W | FDA UDI | Class I | Active |
| Smart Caregiver | TB-45W | FDA UDI | Class I | Active |
| Fall Guardian | FG3C45-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | 4017-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | PPT-5 | FDA UDI | Class I | Active |
| Smart Caregiver | BPC-WI | FDA UDI | Class I | Active |
| Smart Caregiver | CC-02 | FDA UDI | Class I | Active |
| Smart Caregiver | TL-4005SYS | FDA UDI | Class I | Active |
| Smart Caregiver | BFM5-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | CK-01 | FDA UDI | Class I | Active |
| Fall Guardian | FG2000 | FDA UDI | Class I | Active |
| Smart Caregiver | TL-4005 | FDA UDI | Class I | Active |
| Smart Caregiver | 433BW1-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | TL-3015 | FDA UDI | Class I | Active |
| Fall Guardian | FG2C1-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | RP-TL-5102MP | FDA UDI | Class I | Active |
| Smart Caregiver | NCLA-01 | FDA UDI | Class I | Active |
| Fall Guardian | FG2B90W-SYS/CS | FDA UDI | Class I | Active |
| Smart Caregiver | TL-2100G | FDA UDI | Class I | Active |
| Smart Caregiver | PTLM-01C | FDA UDI | Class I | Active |
| Smart Caregiver | PPC-WI | FDA UDI | Class I | Active |
| Fall Guardian | FG2B45R-SYS/CS | FDA UDI | Class I | Active |
| Smart Caregiver | LM-01C | FDA UDI | Class I | Active |
| Smart Caregiver | DVBR1-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | FM-08 | FDA UDI | Class I | Active |
| Smart Caregiver | PTFM-05C | FDA UDI | Class I | Active |
| Smart Caregiver | CPBW90-SYS | FDA UDI | Class I | Active |
| Smart Caregiver | 433S2FM52EC-SYS | FDA UDI | Class I | Active |
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