(119 days)
Not Found
No
The summary describes a simple mechanical device (a mattress) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as a "low air loss flotation therapy mattress," which directly indicates its therapeutic purpose. Additionally, the predicate devices listed are also therapeutic support surfaces.
No
The device description states it is a "Portable powered low air loss flotation therapy mattress," which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "Portable powered low air loss flotation therapy mattress," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator of the device's purpose. IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description "Portable powered low air loss flotation therapy mattress" clearly indicates a device used for patient support and therapy, not for analyzing biological samples.
- Lack of IVD-related information: There is no mention of analyzing samples, diagnostic purposes, or any other activities typically associated with IVDs.
The information provided points to a therapeutic device used for patient care, likely related to pressure ulcer prevention or treatment, as suggested by the "low air loss flotation therapy mattress" description and the predicate devices which are also related to support surfaces.
N/A
Intended Use / Indications for Use
Not Found
Product codes
89IOQ
Device Description
Portable powered low air loss flotation therapy mattress.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Street
Bay Shore, NY 11706
Phone (516) 273-2200
Fax (516) 273-2408 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph Zanetti
Technology & Quality Affairs Manager
Phone (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.