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)

HEEL/ELBOW PROTECTORS

K-Number: K791709 · 1979-09-24

ApplicantFibre Formations, Inc.
Decision Date1979-09-24
Product CodeFMP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEEL/ELBOW PROTECTORS is the device name listed in this FDA 510(k) record. The listed applicant is Fibre Formations, Inc.. It received FDA 510(k) clearance on 1979-09-24 under 510(k) number K791709. The device is classified under product code FMP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEEL/ELBOW PROTECTORS?

HEEL/ELBOW PROTECTORS is a medical device that received FDA 510(k) clearance on 1979-09-24. The listed applicant is Fibre Formations, Inc.. The 510(k) number is K791709.

When did HEEL/ELBOW PROTECTORS receive FDA 510(k) clearance?

HEEL/ELBOW PROTECTORS received FDA 510(k) clearance on 1979-09-24, under 510(k) number K791709.

Who is the listed applicant for HEEL/ELBOW PROTECTORS?

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

What is the FDA product code for HEEL/ELBOW PROTECTORS?

The FDA product code for HEEL/ELBOW PROTECTORS is FMP.

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 Fibre Formations, 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.

K790922DISPOSABLE ADULT DIAPERK781930PANT LINER, DISP. INCONTINENTK781233IV ARMBOARDSK781246FOAM COMFORT RINGS

Related Devices (Code: FMP)

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.

K951325COMFEEL PLUS PRESSURE RELIEF DRESSINGRichard Hamer Assoc., Inc.K934731MEDSURG STERILE IMAGING PRODUCTSMedsurg Industries, Inc.K820584DECUBICARE PADS & ACCESSORIESAbco Dealers, Inc.K812344HEEL OR ELBOW PROTECTORFred Sammons, Inc.K811184SPENCO DERMAL PADSSpenco Medical Corp.K802829SCANLAN VASCU-STATTScanlan Intl., 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.

↑