Air Bed FDA Certified (Alternating Pressure Bubble Mattress)
Pack Sizes Available
Product Description
Technical Specifications
- Certifications: FDA cleared (USA); CE marked (EU); ISO 13485 compatible manufacturing; medical device classification for pressure ulcer prevention and treatment (Stage I and II)
- Mattress Specifications: Dimensions: approx. 200 cm (L) x 90 cm (W) x 6.5 cm (H inflated); 130 individual air bubble cells in alternating pressure groups; material: medical-grade PVC — waterproof, antibacterial, fire-resistant, non-toxic; max patient weight: 130 kg
- Alternating Pressure Cycle: Automatic inflation and deflation cycle: every 6–12 minutes (pump model dependent); alternating groups inflate while adjacent groups deflate to continuously redistribute body pressure and maintain skin blood flow
- Pump Specifications: Electric compressor pump; air output: 4.5–6 L/min; pressure range: 50–130 mmHg; variable pressure control dial; noise level: ≤35 dB; power supply: 110V/220V, 50–60 Hz (dual voltage variants available); bed rail hook included; rated for 24-hour continuous use
- Kit Components: 1 x anti-decubitus bubble mattress with side hangers; 1 x electric air pump with pressure control dial; 1 x connecting air tube; 1 x puncture repair kit; 1 x instruction manual
Frequently asked questions
An anti-decubitus alternating pressure mattress is a medical device designed to prevent and treat pressure ulcers — commonly known as bedsores — in patients who are bedridden or have severely limited mobility. The mattress surface consists of multiple air-filled bubble cells arranged in two alternating groups. An electric pump inflates one group while simultaneously deflating the adjacent group on a timed cycle, typically every 6 to 12 minutes. This constant redistribution of pressure ensures that no single area of the patient's skin is compressed continuously, which preserves blood circulation in the skin and underlying tissue and prevents the oxygen deprivation that causes pressure ulcer development.
The medical anti-decubitus bubble air mattress carries FDA clearance (confirming US regulatory approval for medical device use) and CE marking (confirming conformity with EU medical device regulatory standards). Both certifications are widely recognised as evidence of validated safety and clinical efficacy across import markets globally, including across the Middle East, Africa, and Southeast Asia. Many government hospital and NGO procurement programmes require either FDA or CE marking — or both — as a mandatory condition of purchase. Having both certifications on a single product significantly broadens the markets it can legally be sold into.
The standard medical bubble air mattress supports a maximum patient weight of 130 kg. The electric pump includes a variable pressure control dial that allows the caregiver or nurse to increase or decrease the air pressure delivered to the mattress cells. Adjusting pressure based on the patient's body weight ensures the mattress cells deflate sufficiently during the alternating cycle to actually unload the skin surface — heavier patients require higher base pressure for the alternating mechanism to function effectively. Incorrect pressure settings (too low for a heavy patient) can result in the mattress 'bottoming out' against the bed frame, which negates the pressure-relief function entirely.
The standard anti-decubitus bubble mattress measures approximately 200 cm (length) x 90 cm (width) x 6.5 cm (height when inflated), fitting standard single hospital beds and home cots. The adjustable side hangers or flaps allow the mattress to be secured to most hospital bed frames, preventing displacement during patient turns or repositioning. A king-size variant (wider) is available for larger home beds. The mattress is designed to be placed on top of the existing bed mattress, not as a direct replacement, maintaining the underlying support while adding the pressure-relief function above.
The air pump included with medical-grade anti-decubitus mattresses of this type operates below 35 dB on most variants — quieter than a typical whispered conversation. It is specifically designed for 24-hour continuous operation without overheating or mechanical fatigue. The pump is hung on the bed frame using integrated hooks, keeping it off the floor and stable during use. For patients in shared hospital wards or for homebound patients sleeping alongside family members, the low noise output makes overnight operation practical and non-disruptive.
Each unit is supplied as a complete set — one mattress, one electric air pump with variable pressure dial, one connecting air tube, one puncture repair kit, and one instruction manual, all packaged in a single retail or institutional box. For wholesale and bulk export orders, multiple units are supplied per carton. Sara Wellness handles bulk export orders for hospital procurement programmes, medical retail distributors, and home healthcare supply chains, and can combine air beds with related SKUs under a single export shipment.
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