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FDA 510(k)

MAXI-CHAIR

K-Number: K781801 · 1978-11-03

ApplicantSurgical Mechanical Research, Inc.
Decision Date1978-11-03
Product CodeHME
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAXI-CHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Mechanical Research, Inc.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781801. The device is classified under product code HME. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXI-CHAIR?

MAXI-CHAIR is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Surgical Mechanical Research, Inc.. The 510(k) number is K781801.

When did MAXI-CHAIR receive FDA 510(k) clearance?

MAXI-CHAIR received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781801.

Who is the listed applicant for MAXI-CHAIR?

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

What is the FDA product code for MAXI-CHAIR?

The FDA product code for MAXI-CHAIR is HME.

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 Surgical Mechanical Research, 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.

K803195SYSTEM 1 INSTRUMENT STANDK800382CLEAR-VIEW MIRROR WARMERK800526SMR H-CHAIR

Related Devices (Code: HME)

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.

K930449MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIRMarco Ophthalmic, Inc.K914416BREATH-EASY, MODIFICATIONIcor ABK894018RELIANCE(R) 6200 EXAMINATION CHAIRReliance Medical Products, Inc.K870112STORZ ENT/OPHTHALMIC MAXI CHAIRStorz Instrument Co.K864574MAC 150E OPTHALMIC CHAIRKoken Mfg Company, Inc.K864494MODEL 6500 OPTHALMIC CHAIRKoken Mfg Company, 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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