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FDA 510(k)

DUNLAP HEAT PAD

K-Number: K911195 · 1991-08-12

ApplicantHome Healthcare Products, Inc.
Decision Date1991-08-12
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DUNLAP HEAT PAD is the device name listed in this FDA 510(k) record. The listed applicant is Home Healthcare Products, Inc.. It received FDA 510(k) clearance on 1991-08-12 under 510(k) number K911195. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUNLAP HEAT PAD?

DUNLAP HEAT PAD is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Home Healthcare Products, Inc.. The 510(k) number is K911195.

When did DUNLAP HEAT PAD receive FDA 510(k) clearance?

DUNLAP HEAT PAD received FDA 510(k) clearance on 1991-08-12, under 510(k) number K911195.

Who is the listed applicant for DUNLAP HEAT PAD?

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

What is the FDA product code for DUNLAP HEAT PAD?

The FDA product code for DUNLAP HEAT PAD is IRT.

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 Home Healthcare Products, 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.

K780938SUPER-SORBER

Related Devices (Code: IRT)

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.

K250047bite away twomibeTec GmbHK220514bite away neomibeTec GmbHK160943Bite AwayRiemser PharmaK111273FIR HEAT THERAPHY SYSYEMSShenzhen Anpan Technology Co., Ltd.K072534BIO-MAT 2000Richway Intl., Inc.K963887PT-PAC PORTABLE HEATING PADAnthony A. Chiurco

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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