Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat Arjohuntleigh, Inc. makes
Arjohuntleigh manufactures patient mobility and bathing solutions, including electrically-powered mobile lifting systems, basic and bariatric hospital beds, and alternating-pressure mattress overlays. Their product line also covers hydrotherapy baths and walk-in bathtubs designed for accessibility, as well as general-purpose and specialized patient lifting slings, harnesses, and stretchers. The company produces sliding sheets and other assistive devices to aid patient transfer and positioning in clinical settings.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in hospitals, rehabilitation centers, and home care environments, adhering to regulatory standards for medical devices in the United States.
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 Arjohuntleigh, Inc. manufacture?
Arjohuntleigh, Inc. specializes in patient mobility and bathing solutions. Their product line includes electrically-powered mobile patient lifting systems, basic and bariatric hospital beds, alternating-pressure mattress overlays, hydrotherapy baths, and walk-in bathtubs. They also produce general-purpose and specialized patient lifting slings, harnesses, and stretchers, as well as assistive devices like sliding sheets to aid patient transfers and positioning in clinical settings.
Where is Arjohuntleigh, Inc. based?
Arjohuntleigh, Inc. is headquartered in the United States. The company designs and manufactures its devices with a focus on meeting regulatory requirements for medical equipment in the U.S. market.
Which regulatory registries list Arjohuntleigh’s devices?
Arjohuntleigh’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify and track the devices in use. The UDI system is a key resource for compliance and device identification in the U.S.
How are Arjohuntleigh’s devices classified under FDA regulations?
Arjohuntleigh’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use, potential harm, and complexity, ensuring appropriate regulatory oversight.
What environments are Arjohuntleigh’s devices intended for?
Arjohuntleigh’s devices are designed for use in hospitals, rehabilitation centers, and home care settings. Their products address mobility, bathing accessibility, and patient transfer needs, aligning with clinical environments where patient safety and comfort are prioritized. The range includes both institutional-grade equipment and solutions for home use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (1172)
Page 17 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Primo | AP02211US1100 | FDA UDI | Class II | Active |
| Symbliss Bath | SBS071US00 | FDA UDI | Class II | Active |
| Primo Ferro | AS32212US0100 | FDA UDI | Class II | Active |
| Citadel Plus | FX811B3B3AMABB | FDA UDI | Class II | Active |
| Autologic | PXA201DAR | FDA UDI | Class II | Active |
| Therakair Visio | 413412 | FDA UDI | Class II | Unknown |
| Harmony Bath | AD31801US0001 | FDA UDI | Class II | Active |
| AtmosAir | APOD 25AR | FDA UDI | Class II | Active |
| Maxi Sky 2 | MS021 | FDA UDI | Class I | Active |
| Freedom Bath | AF24104-US | FDA UDI | Class II | Active |
| Harmony Bath | AD31801US0011 | FDA UDI | Class II | Active |
| Harmony Bath | AD32801US2000 | FDA UDI | Class II | Active |
| AtmosAir 9000X | 633035 | FDA UDI | Class I | Active |
| Enterprise | 9813BF111BCUSB | FDA UDI | Class II | Active |
| Primo | AP02211US2100 | FDA UDI | Class II | Active |
| Symbliss | SYBCS001-US | FDA UDI | Class I | Active |
| Freedom Bath | AF24000US00 | FDA UDI | Class II | Active |
| Primo | AP31811US0011 | FDA UDI | Class II | Active |
| Freedom Bath | AF24020US00 | FDA UDI | Class II | Active |
| Primo | AP33801US0010 | FDA UDI | Class II | Active |
| Autologic | PXA001EVE | FDA UDI | Class II | Active |
| Rhapsody | AR02211US1100 | FDA UDI | Class II | Active |
| Sara Plus | HEP1001-US | FDA UDI | Class I | Active |
| Citadel | CXX11C2F3AMAB1 | FDA UDI | Class II | Active |
| AtmosAir Velaris | 633021 | FDA UDI | Class II | Active |
| Maxi Sky 2 | MS235 | FDA UDI | Class I | Active |
| Primo | AP33212US1001 | FDA UDI | Class II | Active |
| Arjo Slides Tube | NSA0800 | FDA UDI | Class I | Active |
| Maxi Sky 2 | MS010-02 | FDA UDI | Class I | Active |
| Citadel | CX611B2F3AMAB1 | FDA UDI | Class II | Active |
| Ninjo | FA1B021CAUS1 | FDA UDI | Class I | Active |
| Citadel | CXX11C3F4AMAB1 | FDA UDI | Class II | Active |
| Carino | BOC1003-01 | FDA UDI | Class I | Active |
| Minuet 2 | 161AN8A1U | FDA UDI | Class II | Active |
| Autologic | 630003 | FDA UDI | Class II | Active |
| Arjo Sling | THA6I-L-33 | FDA UDI | Class I | Active |
| Skin Iq 365 | SIQPSRU04UN | FDA UDI | Class II | Active |
| Flowtron Acs800 | 513003 | FDA UDI | Class II | Unknown |
| Nimbus Professional | 651201EVE | FDA UDI | Class II | Active |
| Enterprise | 9612DC101ADUSB | FDA UDI | Class II | Active |
| Freedom Bath | AF11004US10 | FDA UDI | Class II | Active |
| Primo | AP03211US0010 | FDA UDI | Class II | Active |
| Flowtron | DVT20 | FDA UDI | Class II | Active |
| Primo | AP31811US2001 | FDA UDI | Class II | Active |
| Symbliss Bath | SBL070US01 | FDA UDI | Class II | Active |
| Primo | AP03811US2010 | FDA UDI | Class II | Active |
| Arjo Sling | MAA4160M-L | FDA UDI | Class I | Active |
| Primo | AP03811US1010 | FDA UDI | Class II | Active |
| Rhapsody | AR02211US0110 | FDA UDI | Class II | Active |
| Rik | PPO4002 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.