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FDA 510(k)

SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE

K-Number: K962327 · 1997-03-06

ApplicantSekure Seat Corp.
Decision Date1997-03-06
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sekure Seat Corp.. It received FDA 510(k) clearance on 1997-03-06 under 510(k) number K962327. The device is classified under product code FMQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE?

SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE is a medical device that received FDA 510(k) clearance on 1997-03-06. The listed applicant is Sekure Seat Corp.. The 510(k) number is K962327.

When did SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE receive FDA 510(k) clearance?

SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE received FDA 510(k) clearance on 1997-03-06, under 510(k) number K962327.

Who is the listed applicant for SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE?

The FDA 510(k) record lists Sekure Seat Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE?

The FDA product code for SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE is FMQ.

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Related Devices (Code: FMQ)

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.

K110377PROTECTIVE RESTRAINTMedi-Tech Intl. Corp.K081264STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002Children'S Health First, Inc.K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESTri-State Hospital Supply Corp.K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLESMed Gen, Inc.K010818INFANT LIMB HOLDER, MODELS 306080 & 306081Skil-Care Corp.K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025Skil-Care Corp.

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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