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FDA 510(k)

THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION

K-Number: K895444 · 1989-12-13

ApplicantMcvicar Enterprises, Ltd.
Decision Date1989-12-13
Product CodeINW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION is the device name listed in this FDA 510(k) record. The listed applicant is Mcvicar Enterprises, Ltd.. It received FDA 510(k) clearance on 1989-12-13 under 510(k) number K895444. The device is classified under product code INW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION?

THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION is a medical device that received FDA 510(k) clearance on 1989-12-13. The listed applicant is Mcvicar Enterprises, Ltd.. The 510(k) number is K895444.

When did THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION receive FDA 510(k) clearance?

THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION received FDA 510(k) clearance on 1989-12-13, under 510(k) number K895444.

Who is the listed applicant for THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION?

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

What is the FDA product code for THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION?

The FDA product code for THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION is INW.

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Related Devices (Code: INW)

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

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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