Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PRESSURE GUARD ALTERNATING PRESSURE MATTRESS

K-Number: K954766 · 1996-01-11

ApplicantSpan-America Medical Systems, Inc.
Decision Date1996-01-11
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRESSURE GUARD ALTERNATING PRESSURE MATTRESS is the device name listed in this FDA 510(k) record. The listed applicant is Span-America Medical Systems, Inc.. It received FDA 510(k) clearance on 1996-01-11 under 510(k) number K954766. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURE GUARD ALTERNATING PRESSURE MATTRESS?

PRESSURE GUARD ALTERNATING PRESSURE MATTRESS is a medical device that received FDA 510(k) clearance on 1996-01-11. The listed applicant is Span-America Medical Systems, Inc.. The 510(k) number is K954766.

When did PRESSURE GUARD ALTERNATING PRESSURE MATTRESS receive FDA 510(k) clearance?

PRESSURE GUARD ALTERNATING PRESSURE MATTRESS received FDA 510(k) clearance on 1996-01-11, under 510(k) number K954766.

Who is the listed applicant for PRESSURE GUARD ALTERNATING PRESSURE MATTRESS?

The FDA 510(k) record lists Span-America Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESSURE GUARD ALTERNATING PRESSURE MATTRESS?

The FDA product code for PRESSURE GUARD ALTERNATING PRESSURE MATTRESS is FNM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Span-America Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972486PRESSUREGUARD IVK973169PRESSURE GUARD SITE SELECT (A)K960188PRESSUREGUARD: SELECTCAREK961502LUBRICATING JELLY, LOW VISCOSITYK961159POWERED LOW AIR LOSS MATTRESS SYSTEMK960620PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM

View all 19 devices →

Related Devices (Code: FNM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑