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FDA 510(k)

MYCYCLE HANDMASTER, LIGHT

K-Number: K981558 · 1998-07-09

ApplicantRichvale , Ltd.
Decision Date1998-07-09
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MYCYCLE HANDMASTER, LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Richvale , Ltd.. It received FDA 510(k) clearance on 1998-07-09 under 510(k) number K981558. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYCYCLE HANDMASTER, LIGHT?

MYCYCLE HANDMASTER, LIGHT is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Richvale , Ltd.. The 510(k) number is K981558.

When did MYCYCLE HANDMASTER, LIGHT receive FDA 510(k) clearance?

MYCYCLE HANDMASTER, LIGHT received FDA 510(k) clearance on 1998-07-09, under 510(k) number K981558.

Who is the listed applicant for MYCYCLE HANDMASTER, LIGHT?

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

What is the FDA product code for MYCYCLE HANDMASTER, LIGHT?

The FDA product code for MYCYCLE HANDMASTER, LIGHT is IOR.

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.

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Other records listing Richvale , 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.

K981557MYCYCLE, HANDMASTER, VICTORY

Related Devices (Code: IOR)

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.

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Official Source

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