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)

REUSABLE MOIST HEAT PACK

K-Number: K791653 · 1979-09-07

ApplicantTru-Eze Mfg. Co., Inc.
Decision Date1979-09-07
Product CodeIMA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REUSABLE MOIST HEAT PACK is the device name listed in this FDA 510(k) record. The listed applicant is Tru-Eze Mfg. Co., Inc.. It received FDA 510(k) clearance on 1979-09-07 under 510(k) number K791653. 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 REUSABLE MOIST HEAT PACK?

REUSABLE MOIST HEAT PACK is a medical device that received FDA 510(k) clearance on 1979-09-07. The listed applicant is Tru-Eze Mfg. Co., Inc.. The 510(k) number is K791653.

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

REUSABLE MOIST HEAT PACK received FDA 510(k) clearance on 1979-09-07, under 510(k) number K791653.

Who is the listed applicant for REUSABLE MOIST HEAT PACK?

The FDA 510(k) record lists Tru-Eze Mfg. Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REUSABLE MOIST HEAT PACK?

The FDA product code for REUSABLE 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 Tru-Eze Mfg. Co., 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.

K801625THERMOLATOR HEATING UNITK800917TRU-COLD THERAPY PAK

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.K803177MOIST HEAT PACKDuro-Med Ind., 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.

↑