Identity
- Trade Name
- SideLyer FDA UDI
- Generic Name
- Kinetic bed FDA UDI
- Device Name
- The SideLyer Adjustable Patient Bed (APB) is an AC-powered adjustable bed where the caregiver can adjust the bed position at various angles. The SideLyer APB supports patients who are in restricted positions or long term bed use due to lack of mobility or other issues. The APB is moveable, but can be locked in a stationary position. It has a padded horizontal surface and a flat padded vertical surface on one side so that patients can be positioned to lie on their side. The device may be rotated by the patient or caregiver using the device controller at different angles. The benefit of the SideLyer APB’s repositioning to the patient is to relieve or distribute pressure. Repositioning is a fundamental component of pressure ulcer prevention (PUP), including reducing or eliminating bedsores and decubitus ulcers. Repositioning also serves to increase blood flow and transcutaneous oxygen tension, reducing the likelihood of anoxic levels of oxygen and decrease localized interface pressure. Repositioning prevents complications such as pneumonia, joint contractures, and urinary tract infections. FDA UDI
- Model / Reference
- SLB01 FDA UDI
- Description
- The SideLyer Adjustable Patient Bed (APB) is an AC-powered adjustable bed where the caregiver can adjust the bed position at various angles. The SideLyer APB supports patients who are in restricted positions or long term bed use due to lack of mobility or other issues. The APB is moveable, but can be locked in a stationary position. It has a padded horizontal surface and a flat padded vertical surface on one side so that patients can be positioned to lie on their side. The device may be rotated by the patient or caregiver using the device controller at different angles. The benefit of the SideLyer APB’s repositioning to the patient is to relieve or distribute pressure. Repositioning is a fundamental component of pressure ulcer prevention (PUP), including reducing or eliminating bedsores and decubitus ulcers. Repositioning also serves to increase blood flow and transcutaneous oxygen tension, reducing the likelihood of anoxic levels of oxygen and decrease localized interface pressure. Repositioning prevents complications such as pneumonia, joint contractures, and urinary tract infections. FDA UDI
Identifiers
- Catalog Number
- SL01 FDA UDI
- Primary DI / UDI-DI
- 00860011685609 FDA UDI
- FDA Product Code
- IKZ FDA UDI
- GMDN Term
- Kinetic bed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5225 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 47 Inch FDA UDIDepth — 34.75 Inch FDA UDIHeight — 85.25 Inch FDA UDI
Category: Kinetic bed
SideLyer by The Side Lyer Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- The Side Lyer Company
Sources (1)
- FDA UDI 12ff05e6-5d4c-44e8-bb67-abd5ca38d290 37 fields · synced May 30, 2026