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FDA 510(k)

HEELBO WRAP AROUND VEST

K-Number: K963294 · 1996-10-11

ApplicantHeelbo, Inc.
Decision Date1996-10-11
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEELBO WRAP AROUND VEST is the device name listed in this FDA 510(k) record. The listed applicant is Heelbo, Inc.. It received FDA 510(k) clearance on 1996-10-11 under 510(k) number K963294. 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 HEELBO WRAP AROUND VEST?

HEELBO WRAP AROUND VEST is a medical device that received FDA 510(k) clearance on 1996-10-11. The listed applicant is Heelbo, Inc.. The 510(k) number is K963294.

When did HEELBO WRAP AROUND VEST receive FDA 510(k) clearance?

HEELBO WRAP AROUND VEST received FDA 510(k) clearance on 1996-10-11, under 510(k) number K963294.

Who is the listed applicant for HEELBO WRAP AROUND VEST?

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

What is the FDA product code for HEELBO WRAP AROUND VEST?

The FDA product code for HEELBO WRAP AROUND VEST is FMQ.

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Other records listing Heelbo, 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.

K980640HEELBO WAIST AND CHEST VESTK963372HEELBO ER WRIST RESTRAINTK963060HEELBO SECURITY BELTK963099HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKETK963041HEELBO LIFE JACKET WITH CROTCH SUPPORTK962834HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP

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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

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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