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FDA 510(k)

RE-HEATER, HOT PACK

K-Number: K863654 · 1986-10-23

ApplicantK & L Ent.
Decision Date1986-10-23
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RE-HEATER, HOT PACK is the device name listed in this FDA 510(k) record. The listed applicant is K & L Ent.. It received FDA 510(k) clearance on 1986-10-23 under 510(k) number K863654. 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 RE-HEATER, HOT PACK?

RE-HEATER, HOT PACK is a medical device that received FDA 510(k) clearance on 1986-10-23. The listed applicant is K & L Ent.. The 510(k) number is K863654.

When did RE-HEATER, HOT PACK receive FDA 510(k) clearance?

RE-HEATER, HOT PACK received FDA 510(k) clearance on 1986-10-23, under 510(k) number K863654.

Who is the listed applicant for RE-HEATER, HOT PACK?

The FDA 510(k) record lists K & L Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RE-HEATER, HOT PACK?

The FDA product code for RE-HEATER, HOT PACK is IME.

Related Clinical Trials

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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 ProductsK915876HOTPADTen Comfort Corp.K921446HOT OR COLD PACK (THERMIPAQ)Thermionics Corp.K905207MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESSMicro Surgical Instruments Corp.K882413SUBOCCIPITAL ICE PILLOWFerguson MedicalK832193NICE PACKUniversal Medical Instrument Corp.

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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