Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET

K-Number: K963099 · 1996-11-01

ApplicantHeelbo, Inc.
Decision Date1996-11-01
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET is the device name listed in this FDA 510(k) record. The listed applicant is Heelbo, Inc.. It received FDA 510(k) clearance on 1996-11-01 under 510(k) number K963099. 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 PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET?

HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET is a medical device that received FDA 510(k) clearance on 1996-11-01. The listed applicant is Heelbo, Inc.. The 510(k) number is K963099.

When did HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET receive FDA 510(k) clearance?

HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET received FDA 510(k) clearance on 1996-11-01, under 510(k) number K963099.

Who is the listed applicant for HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET?

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 PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET?

The FDA product code for HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET 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 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 BELTK963041HEELBO LIFE JACKET WITH CROTCH SUPPORTK962831THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSUREK962834HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP

View all 14 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.

↑