Who is the manufacturer of PRESSUREGUARD: SELECTCARE?

Span-America Medical Systems, Inc. filed the 510(k) submission for PRESSUREGUARD: SELECTCARE (K960188).

What is the FDA product code for PRESSUREGUARD: SELECTCARE?

FNM. It is classified under 21 CFR 880.5550 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for PRESSUREGUARD: SELECTCARE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PRESSUREGUARD: SELECTCARE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PRESSUREGUARD: SELECTCARE

K960188 · Span-America Medical Systems, Inc. · FNM · Oct 2, 1996 · General Hospital

Device Facts

Record ID	K960188
Device Name	PRESSUREGUARD: SELECTCARE
Applicant	Span-America Medical Systems, Inc.
Product Code	FNM · General Hospital
Decision Date	Oct 2, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5550
Device Class	Class 2
Attributes	Therapeutic

Intended Use

For the prevention and treatment of pressure ulcers.

Device Story

Powered air flotation mattress; provides pressure-reducing support; adjustable firmness for patient comfort; includes CPR mode for firm surface during resuscitation. Used in clinical settings; operated by healthcare staff. Output is physical support surface; affects patient positioning and pressure distribution; benefits include pressure ulcer prevention and treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered air flotation mattress system; adjustable firmness controls; integrated CPR mode for surface firming. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring pressure ulcer prevention and treatment; suitable for individuals needing adjustable firmness support.

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.

Predicate Devices

PressureGuard IV (K951112)

Related Devices

K961159 — POWERED LOW AIR LOSS MATTRESS SYSTEM · Span-America Medical Systems, Inc. · Jun 14, 1996
K974319 — MIGHTY AIR · Wheelchairs of Kansas · Jan 22, 1998
K970081 — SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM · Cathay Consolidated, Inc. · Nov 7, 1997
K963674 — LUMEX AIR · Lumex, Inc. · Jan 10, 1997
K960620 — PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM · Span-America Medical Systems, Inc. · Apr 25, 1996

Submission Summary (Full Text)

{0} SPAN-AMERICA MEDICAL SYSTEMS, INC. K960188 OCT - 2 1996 # PRESSUREGUARD: SELECT CARE ## 510K SUMMARY 1.0. Submitter: Span-America Medical Systems, Inc. Address: 70 Commerce Drive; Greenville, SC 29615 Telephone: (864) 288-8877 Contact Person: Charles B. Mitchell, President & CEO Wanda J. Totton, Director of Quality Date Prepared: January 8, 1995 2.0. Trade Name: PressureGuard: SelectCare Mattress System Common Name: Powered Air Flotation Mattress Classification Name: Unknown 3.0. Predicate Device: PressureGuard IV, 510K951112 4.0. Description: The PressureGuard SelectCare is a powered air flotation mattress which provides pressure-reducing support within a range of adjustable firmness to meet individual comfort needs. The system also includes a CPR mode, providing a firm surface for performing CPR. 5.0. Indications for Use: For the prevention and treatment of pressure ulcers. 6.0. Substantial Equivalence: The product is similar in function and intended use to the PressureGuard IV, 510K951112 for the Center and CPR Modes. P.O. Box 5231, Greenville, S.C. 29606 • 803-288-8877 • FAX 803-288-8692