Stage Zero Air Flotation Bed
by Lake Medical Products, Inc. 510(k)
Active
510(k) K905053
Overview
The Stage Zero Air Flotation Bed is a Powered Flotation Therapy Bed (Device Type: Bed, Flotation Therapy, Powered) designed to alternate air pressure within multiple integrated cells. This mechanism redistributes body weight dynamically to reduce sustained pressure points, mitigating the risk of pressure ulcers and promoting patient comfort during prolonged immobility. Its function relies on an automated control unit that cycles air inflation and deflation in a programmed sequence, ensuring consistent pressure relief across the mattress surface.
This device is supplied as a reusable, non-sterile medical system intended for clinical use in physical medicine settings. It requires connection to a standard electrical outlet for operation and is classified under FDA regulation 890.5170 as a Class II device, with clearance via FDA 510(k) K905053 (Traditional Review, Substantially Equivalent determination). The mattress features 16 independent air cells (as referenced in comparative literature) and is not MRI-compatible. Storage should follow manufacturer guidelines to prevent damage to the air cells and control unit components.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905053 | Date26 Nov 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IOQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5170
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Lake Medical Products, Inc.
Questions
What is the Stage Zero Air Flotation Bed designed to do?
The Stage Zero Air Flotation Bed is engineered to alternate air pressure across 16 integrated cells, dynamically redistributing body weight. This reduces sustained pressure points, lowering the risk of pressure ulcers and improving comfort for patients during prolonged immobility. The automated control unit cycles inflation and deflation in a programmed sequence to ensure even pressure relief.
Is the Stage Zero Air Flotation Bed reusable or single-use?
The Stage Zero Air Flotation Bed is supplied as a reusable medical system. It is intended for clinical use in physical medicine settings and requires proper maintenance to preserve its functionality, including the air cells and control unit components. Reusability aligns with its classification as a non-sterile device.
How many air cells does the mattress contain, and what does this mean for pressure relief?
The mattress features 16 independent air cells, which allow for targeted pressure redistribution. Each cell inflates and deflates in sequence, ensuring that no single area bears prolonged pressure. This design helps mitigate pressure ulcers by continuously shifting weight distribution across the body surface.
What electrical requirements does the Stage Zero Air Flotation Bed have?
The Stage Zero Air Flotation Bed requires connection to a standard electrical outlet for operation. It is powered to cycle its air cells automatically, so a consistent power source is essential for its function. Always follow manufacturer guidelines to ensure safe and reliable use.
How should the Stage Zero Air Flotation Bed be stored?
Storage should follow manufacturer guidelines to prevent damage to the air cells and control unit components. Avoid bending, folding, or exposing the mattress to sharp objects, extreme temperatures, or direct sunlight. Proper storage ensures the device remains functional and safe for clinical use.