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FDA 510(k)

MOIST HEAT PACK

K-Number: K803177 · 1980-12-31

ApplicantDuro-Med Ind., Inc.
Decision Date1980-12-31
Product CodeIMA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MOIST HEAT PACK is the device name listed in this FDA 510(k) record. The listed applicant is Duro-Med Ind., Inc.. It received FDA 510(k) clearance on 1980-12-31 under 510(k) number K803177. The device is classified under product code IMA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOIST HEAT PACK?

MOIST HEAT PACK is a medical device that received FDA 510(k) clearance on 1980-12-31. The listed applicant is Duro-Med Ind., Inc.. The 510(k) number is K803177.

When did MOIST HEAT PACK receive FDA 510(k) clearance?

MOIST HEAT PACK received FDA 510(k) clearance on 1980-12-31, under 510(k) number K803177.

Who is the listed applicant for MOIST HEAT PACK?

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

What is the FDA product code for MOIST HEAT PACK?

The FDA product code for MOIST HEAT PACK is IMA.

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 Duro-Med Ind., 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.

K823903RUBBER INFLATABLE RING

Related Devices (Code: IMA)

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.

K950701WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLERWahl Clipper Corp.K841698HEAT PACKMaddak, Inc.K832803STEAM PAK MOIST HEATElectro-Med Health Industries, Inc.K823622INSULATED THERMOELASTOMER MITTFred Sammons, Inc.K791653REUSABLE MOIST HEAT PACKTru-Eze Mfg. Co., Inc.K790904STAO-HOTPACKStaodynamics, 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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