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FDA 510(k)

ERGOSEAT SYSTEM

K-Number: K954162 · 1995-10-30

ApplicantErgo-Air, Inc.
Decision Date1995-10-30
Product CodeMOC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ERGOSEAT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ergo-Air, Inc.. It received FDA 510(k) clearance on 1995-10-30 under 510(k) number K954162. The device is classified under product code MOC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERGOSEAT SYSTEM?

ERGOSEAT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-30. The listed applicant is Ergo-Air, Inc.. The 510(k) number is K954162.

When did ERGOSEAT SYSTEM receive FDA 510(k) clearance?

ERGOSEAT SYSTEM received FDA 510(k) clearance on 1995-10-30, under 510(k) number K954162.

Who is the listed applicant for ERGOSEAT SYSTEM?

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

What is the FDA product code for ERGOSEAT SYSTEM?

The FDA product code for ERGOSEAT SYSTEM is MOC.

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 Ergo-Air, 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.

K952093ERGOMAT 5000 SYSTEMK952092ERGOMAT 8000 SYSTEM

Related Devices (Code: MOC)

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.

K063175IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)Medical Technology 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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