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)

HOTPAD

K-Number: K915876 · 1993-02-12

ApplicantTen Comfort Corp.
Decision Date1993-02-12
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOTPAD is the device name listed in this FDA 510(k) record. The listed applicant is Ten Comfort Corp.. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K915876. The device is classified under product code IME. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOTPAD?

HOTPAD is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Ten Comfort Corp.. The 510(k) number is K915876.

When did HOTPAD receive FDA 510(k) clearance?

HOTPAD received FDA 510(k) clearance on 1993-02-12, under 510(k) number K915876.

Who is the listed applicant for HOTPAD?

The FDA 510(k) record lists Ten Comfort Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOTPAD?

The FDA product code for HOTPAD is IME.

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

Related Devices (Code: IME)

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.

K923627COLD PACKFriendmed ProductsK921446HOT OR COLD PACK (THERMIPAQ)Thermionics Corp.K905207MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESSMicro Surgical Instruments Corp.K882413SUBOCCIPITAL ICE PILLOWFerguson MedicalK863654RE-HEATER, HOT PACKK & L Ent.K832193NICE PACKUniversal Medical Instrument Corp.

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.

↑