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Portable powered low air loss flotation therapy mattress.
This document, K963674, is a 510(k) summary for the LUMEXAIR portable powered low air loss flotation therapy mattress. It is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
There is no information in this document regarding a clinical study to prove the device meets acceptance criteria.
The document primarily focuses on establishing "substantial equivalence" of the LUMEXAIR mattress to other legally marketed predicate devices, such as the Orthoderm HC System®, Akrotech 4000®, and Plexus 3000®. This means the submission argues that the new device is as safe and effective as these existing devices, often by demonstrating similar design, materials, and intended use.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because these details are not present in the provided 510(k) summary. The 510(k) process for devices like this typically relies on performance data and comparisons to predicate devices, rather than robust clinical trials with specific acceptance criteria as you might see for novel, high-risk devices or pharmaceuticals.
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JAN 1 0 1997
Image /page/0/Picture/2 description: The image shows the logo for Lumex Medical Products Inc. The word "LUMEX" is in large, bold, black letters. Underneath "LUMEX" is the text "A Fuque Enterprises Company Inc." in a smaller font. To the right of "LUMEX" is the text "Medical Products Inc." in a smaller, regular font.
LUMEXAIR
510(k) Summary 1.0
| Submitter: | Lumex Medical Products, Inc.100 Spence StreetBay Shore, NY 11706Phone (516) 273-2200Fax (516) 273-2408 |
|---|---|
| Contact Person: | Joseph ZanettiTechnology & Quality Affairs ManagerPhone (516) 273-2200 Extension 443 |
| Classification Name: | Low air loss zero pressure mattress flotation therapy -89IOQ(890.5170) |
| Common or Usual Name: | Portable powered low air loss flotation therapy mattress. |
| Proprietary Name: | LUMEXAIR |
| Establishment Registration Number: | 2427360 |
| Classification: | Class II |
| Performance Standard: | None established under section 514 |
Labeling/Promotional Material: See enclosed Table of Contents
Substantial Equivalence: This product is similar in design, composition and function to the Orthoderm HC System® (350513) manufactured by Bio Clinic a division of Sunrise Medical, as well as, the Akrotech 4000® manufactured by Lumex Medical Products and as well as, the Plexus 3000® manufactured by Plexus Medical remanufactured and distributed by Lumex Medical Products Incorporated under the ALTAIR product line. Please note that both the LUMEX/Plexus 3000@ and the LUMEX/Akrotech 4000® have already received 510(k) status and evidence of this is copied in Appendix IV, reference K952610, dated September 7, 1995, by Timothy A. Ulatowski, Acting Director, Pilot Division; reference K923977, dated September 4, 1992, by Paul R. Beninger, M.D., Acting Director, General and Restorative Devices Division respectively.
§ 880.5550 Alternating pressure air flotation mattress.
(a)
Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.