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)

MARUKYR-BAN / HOT OR HEAT PACK

K-Number: K850566 · 1985-05-29

ApplicantOriental Medical Supplies, Inc.
Decision Date1985-05-29
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MARUKYR-BAN / HOT OR HEAT 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 1985-05-29 under 510(k) number K850566. 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 MARUKYR-BAN / HOT OR HEAT PACK?

MARUKYR-BAN / HOT OR HEAT PACK is a medical device that received FDA 510(k) clearance on 1985-05-29. The listed applicant is Oriental Medical Supplies, Inc.. The 510(k) number is K850566.

When did MARUKYR-BAN / HOT OR HEAT PACK receive FDA 510(k) clearance?

MARUKYR-BAN / HOT OR HEAT PACK received FDA 510(k) clearance on 1985-05-29, under 510(k) number K850566.

Who is the listed applicant for MARUKYR-BAN / HOT OR HEAT 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 MARUKYR-BAN / HOT OR HEAT PACK?

The FDA product code for MARUKYR-BAN / HOT OR HEAT PACK is IMD.

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 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)K852610HOT 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.

↑