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FDA 510(k)

HEEL PROTECTOR

K-Number: K771633 · 1977-09-12

ApplicantMedical Restraints, Inc.
Decision Date1977-09-12
Product CodeFMP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEEL PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Restraints, Inc.. It received FDA 510(k) clearance on 1977-09-12 under 510(k) number K771633. 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 PROTECTOR?

HEEL PROTECTOR is a medical device that received FDA 510(k) clearance on 1977-09-12. The listed applicant is Medical Restraints, Inc.. The 510(k) number is K771633.

When did HEEL PROTECTOR receive FDA 510(k) clearance?

HEEL PROTECTOR received FDA 510(k) clearance on 1977-09-12, under 510(k) number K771633.

Who is the listed applicant for HEEL PROTECTOR?

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

What is the FDA product code for HEEL PROTECTOR?

The FDA product code for HEEL PROTECTOR 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 Medical Restraints, 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.

K771636BODY RESTRAINTK771630LIMB RESTRAINTK771629HAND RESTRAINTK771634VEST RESTRAINTK771635FOOT ELEVATORK771715PELVIC WHEELCHAIR RESTRAINT

View all 10 devices →

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.

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