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FDA 510(k)

UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS

K-Number: K963527 · 1996-10-31

ApplicantAlimed, Inc.
Decision Date1996-10-31
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS is the device name listed in this FDA 510(k) record. The listed applicant is Alimed, Inc.. It received FDA 510(k) clearance on 1996-10-31 under 510(k) number K963527. 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 UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS?

UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS is a medical device that received FDA 510(k) clearance on 1996-10-31. The listed applicant is Alimed, Inc.. The 510(k) number is K963527.

When did UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS receive FDA 510(k) clearance?

UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS received FDA 510(k) clearance on 1996-10-31, under 510(k) number K963527.

Who is the listed applicant for UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS?

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

What is the FDA product code for UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS?

The FDA product code for UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS is FMQ.

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 Alimed, 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.

K963528ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)K963526STRAP WEDGEK920487MINI VIBRATORK840156PROTECTA COAT SPONGESK822650SUPER DONUTK822651TOTAL FINGER FLEXION SPLINT

View all 11 devices →

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

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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