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The Apex Metal AirTec2 Low Air Loss Therapy Bed is indicated for pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery, that may be in Neurology, Dermatology, Rehabilitation or Orthopedics. For pain management and pressure relief consider the AirTec2 for patients with arthritis, AIDS or cancer.

AirTec2™ Low Air Loss Therapy Bed

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the HydroTec™ Low Air Loss Therapy Bed and AirTec2™ Low Air Loss Therapy Bed, indicating they are substantially equivalent to devices marketed prior to May 28, 1976. This type of document typically does not contain details of specific performance studies or acceptance criteria beyond regulatory compliance.

The information provided only includes:

• Trade Name: HydroTec™ Low Air Loss Therapy Bed and AirTec2™ Low Air Loss Therapy Bed
• Regulatory Class: II
• Product Code: IOQ
• Indications for Use: Pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery (in Neurology, Dermatology, Rehabilitation or Orthopedics), and pain management and pressure relief for patients with arthritis, AIDS or cancer.

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