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FDA 510(k)

AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS

K-Number: K852036 · 1985-09-05

ApplicantAir Plus, Inc.
Decision Date1985-09-05
Product CodeINX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Air Plus, Inc.. It received FDA 510(k) clearance on 1985-09-05 under 510(k) number K852036. The device is classified under product code INX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS?

AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS is a medical device that received FDA 510(k) clearance on 1985-09-05. The listed applicant is Air Plus, Inc.. The 510(k) number is K852036.

When did AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS receive FDA 510(k) clearance?

AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS received FDA 510(k) clearance on 1985-09-05, under 510(k) number K852036.

Who is the listed applicant for AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS?

The FDA 510(k) record lists Air Plus, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS?

The FDA product code for AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS is INX.

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

Related Devices (Code: INX)

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.

K972176HOME CARE BEAD BEDKinetic Concepts, Inc.K964223CLINITRON RITE-HITEHill-Rom, Inc.K943385CLINITRON ELEXISSsi Medical Services, Inc.K942184CLINITRON AT HOME AIR FLUIDED THERAPYSsi Medical Services, Inc.K931168X-20 AIR SUPPORT BEDAmerican Life Support Technology, Inc.K934689LOW AIR LOSS MATTRESS, MODIFICATIONCardio Systems, Inc.

Official Source

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

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