FDA 510(k)

HOT OR HEAT PACK

K-Number: K853148 · 1985-09-25

Decision Date1985-09-25

Product CodeIMD

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

HOT OR HEAT PACK is the device name listed in this FDA 510(k) record. The listed applicant is Matrix Intl.. It received FDA 510(k) clearance on 1985-09-25 under 510(k) number K853148. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOT OR HEAT PACK?

HOT OR HEAT PACK is a medical device that received FDA 510(k) clearance on 1985-09-25. The listed applicant is Matrix Intl.. The 510(k) number is K853148.

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

HOT OR HEAT PACK received FDA 510(k) clearance on 1985-09-25, under 510(k) number K853148.

Who is the listed applicant for HOT OR HEAT PACK?

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

What is the FDA product code for HOT OR HEAT PACK?

The FDA product code for HOT OR HEAT PACK is IMD.

Related Devices (Code: IMD)

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.

K221653InfaTherm Disposable Infant Warming MattressInternational Biomedical K163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.K112547NEO NESTDenovo Proucts, LLC K082087EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)Johnson & Johnson Consumer Products, Inc.K021843EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.

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.