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)

HOT PACK

K-Number: K852610 · 1985-08-12

ApplicantOriental Medical Supplies, Inc.
Decision Date1985-08-12
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOT PACK is the device name listed in this FDA 510(k) record. The listed applicant is Oriental Medical Supplies, Inc.. It received FDA 510(k) clearance on 1985-08-12 under 510(k) number K852610. 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 PACK?

HOT PACK is a medical device that received FDA 510(k) clearance on 1985-08-12. The listed applicant is Oriental Medical Supplies, Inc.. The 510(k) number is K852610.

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

HOT PACK received FDA 510(k) clearance on 1985-08-12, under 510(k) number K852610.

Who is the listed applicant for HOT PACK?

The FDA 510(k) record lists Oriental Medical Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOT PACK?

The FDA product code for HOT PACK is IMD.

Other records listing Oriental Medical Supplies, 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.

K893372LATEX EXAMINATION GLOVESK871666MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATORK853442MODEL 804 (TENS)K853416MES-TENS(TENS)K850566MARUKYR-BAN / HOT OR HEAT PACK

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 BiomedicalK163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.K112547NEO NESTDenovo Proucts, LLCK082087EYEFEEL 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑