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FDA 510(k)

STAGE IV, AIR-FLUIDIZE BED

K-Number: K904008 · 1990-10-10

ApplicantUnique Flotation Systems, Inc.
Decision Date1990-10-10
Product CodeINX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STAGE IV, AIR-FLUIDIZE BED is the device name listed in this FDA 510(k) record. The listed applicant is Unique Flotation Systems, Inc.. It received FDA 510(k) clearance on 1990-10-10 under 510(k) number K904008. 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 STAGE IV, AIR-FLUIDIZE BED?

STAGE IV, AIR-FLUIDIZE BED is a medical device that received FDA 510(k) clearance on 1990-10-10. The listed applicant is Unique Flotation Systems, Inc.. The 510(k) number is K904008.

When did STAGE IV, AIR-FLUIDIZE BED receive FDA 510(k) clearance?

STAGE IV, AIR-FLUIDIZE BED received FDA 510(k) clearance on 1990-10-10, under 510(k) number K904008.

Who is the listed applicant for STAGE IV, AIR-FLUIDIZE BED?

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

What is the FDA product code for STAGE IV, AIR-FLUIDIZE BED?

The FDA product code for STAGE IV, AIR-FLUIDIZE BED 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

Other records listing Unique Flotation 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.

K903659STAGE III

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

View on FDA Database →

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

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