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FDA 510(k)

AUTOGEL PAD

K-Number: K031018 · 2003-12-08

ApplicantRich-Mar Corp.
Decision Date2003-12-08
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AUTOGEL PAD is the device name listed in this FDA 510(k) record. The listed applicant is Rich-Mar Corp.. It received FDA 510(k) clearance on 2003-12-08 under 510(k) number K031018. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOGEL PAD?

AUTOGEL PAD is a medical device that received FDA 510(k) clearance on 2003-12-08. The listed applicant is Rich-Mar Corp.. The 510(k) number is K031018.

When did AUTOGEL PAD receive FDA 510(k) clearance?

AUTOGEL PAD received FDA 510(k) clearance on 2003-12-08, under 510(k) number K031018.

Who is the listed applicant for AUTOGEL PAD?

The FDA 510(k) record lists Rich-Mar Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOGEL PAD?

The FDA product code for AUTOGEL PAD is MUI.

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Other records listing Rich-Mar Corp. 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.

K040679RICH-MAR AUTOPRISM INFRARED LAMPK032941AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICEK021483RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUNDK013770MODIFICATION TO: WINNER ST-2 STIMULATORK013771MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICEK012848WINNER CM4 COMBINATION UNIT

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Related Devices (Code: MUI)

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.

K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd.K252337EdgeFlow Gel PadEdgecare, Inc.K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd.K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.K221999Ultrasound Transmission GelsHony Medical Co., Ltd.

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.

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