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FDA 510(k)

WINNER CM4 COMBINATION UNIT

K-Number: K012848 · 2001-10-25

ApplicantRich-Mar Corp.
Decision Date2001-10-25
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WINNER CM4 COMBINATION UNIT 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 2001-10-25 under 510(k) number K012848. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WINNER CM4 COMBINATION UNIT?

WINNER CM4 COMBINATION UNIT is a medical device that received FDA 510(k) clearance on 2001-10-25. The listed applicant is Rich-Mar Corp.. The 510(k) number is K012848.

When did WINNER CM4 COMBINATION UNIT receive FDA 510(k) clearance?

WINNER CM4 COMBINATION UNIT received FDA 510(k) clearance on 2001-10-25, under 510(k) number K012848.

Who is the listed applicant for WINNER CM4 COMBINATION UNIT?

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 WINNER CM4 COMBINATION UNIT?

The FDA product code for WINNER CM4 COMBINATION UNIT is GZJ.

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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 LAMPK031018AUTOGEL PADK032941AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICEK021483RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUNDK013771MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICEK013770MODIFICATION TO: WINNER ST-2 STIMULATOR

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Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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