K963674 · Lumex, Inc. · FNM · Jan 10, 1997 · General Hospital
Device Facts
Record ID
K963674
Device Name
LUMEX AIR
Applicant
Lumex, Inc.
Product Code
FNM · General Hospital
Decision Date
Jan 10, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5550
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Portable powered low air loss flotation therapy mattress.
Device Story
Portable powered low air loss flotation therapy mattress; provides pressure redistribution via air-filled cells; used in clinical or home settings to prevent or treat pressure ulcers; operated by healthcare providers or caregivers; system maintains patient support surface through controlled air inflation/deflation cycles; reduces interface pressure to promote tissue healing and prevent skin breakdown.
Technological Characteristics
Powered low air loss flotation therapy mattress; consists of air-filled cells and control unit for inflation/deflation; Class II device; no performance standards established under section 514.
Indications for Use
Indicated for patients requiring low air loss zero pressure mattress flotation therapy for the prevention or treatment of pressure ulcers.
Regulatory Classification
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).
Special Controls
*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.
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K963674
JAN 10 1997
LUMEX Medical Products Inc.
A Puque Enterprises Company Inc.
# LUMEXAIR
## 1.0 510(k) Summary
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.
