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FDA 510(k)

THERMASSAGE ENERGY PRODUCT, MODEL HY5000

K-Number: K032449 · 2003-10-22

ApplicantMigun Medical Instrument Co. , Ltd.
Decision Date2003-10-22
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMASSAGE ENERGY PRODUCT, MODEL HY5000 is the device name listed in this FDA 510(k) record. The listed applicant is Migun Medical Instrument Co. , Ltd.. It received FDA 510(k) clearance on 2003-10-22 under 510(k) number K032449. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMASSAGE ENERGY PRODUCT, MODEL HY5000?

THERMASSAGE ENERGY PRODUCT, MODEL HY5000 is a medical device that received FDA 510(k) clearance on 2003-10-22. The listed applicant is Migun Medical Instrument Co. , Ltd.. The 510(k) number is K032449.

When did THERMASSAGE ENERGY PRODUCT, MODEL HY5000 receive FDA 510(k) clearance?

THERMASSAGE ENERGY PRODUCT, MODEL HY5000 received FDA 510(k) clearance on 2003-10-22, under 510(k) number K032449.

Who is the listed applicant for THERMASSAGE ENERGY PRODUCT, MODEL HY5000?

The FDA 510(k) record lists Migun Medical Instrument Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMASSAGE ENERGY PRODUCT, MODEL HY5000?

The FDA product code for THERMASSAGE ENERGY PRODUCT, MODEL HY5000 is JFB.

Related Clinical Trials

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Other records listing Migun Medical Instrument Co. , Ltd. 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.

K041200THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000

Related Devices (Code: JFB)

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.

K250266Ceragem Automatic Thermal Massager (CGM MB-2401)Ceragem Co., Ltd.K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)Marzzan Lucas JorgeK243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)Ceragem Co., Ltd.K243355Ceragem Automatic Thermal Massager (CGM-MB-1902)Ceragem Co., Ltd.K240168N7-SNuga Medical Co., Ltd.K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd.

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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