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FDA 510(k)

WHEEL LEMASTER

K-Number: K954370 · 1995-11-29

ApplicantHeliarc Specialists, Inc.
Decision Date1995-11-29
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WHEEL LEMASTER is the device name listed in this FDA 510(k) record. The listed applicant is Heliarc Specialists, Inc.. It received FDA 510(k) clearance on 1995-11-29 under 510(k) number K954370. 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 WHEEL LEMASTER?

WHEEL LEMASTER is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Heliarc Specialists, Inc.. The 510(k) number is K954370.

When did WHEEL LEMASTER receive FDA 510(k) clearance?

WHEEL LEMASTER received FDA 510(k) clearance on 1995-11-29, under 510(k) number K954370.

Who is the listed applicant for WHEEL LEMASTER?

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

What is the FDA product code for WHEEL LEMASTER?

The FDA product code for WHEEL LEMASTER is IOR.

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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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