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FDA 510(k)

HT-WEDGE

K-Number: K121287 · 2012-10-03

ApplicantD.T. Davis Enterprises Ltd. T/A Hovertech Int'L
Decision Date2012-10-03
Product CodeFNG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HT-WEDGE is the device name listed in this FDA 510(k) record. The listed applicant is D.T. Davis Enterprises Ltd. T/A Hovertech Int'L. It received FDA 510(k) clearance on 2012-10-03 under 510(k) number K121287. The device is classified under product code FNG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HT-WEDGE?

HT-WEDGE is a medical device that received FDA 510(k) clearance on 2012-10-03. The listed applicant is D.T. Davis Enterprises Ltd. T/A Hovertech Int'L. The 510(k) number is K121287.

When did HT-WEDGE receive FDA 510(k) clearance?

HT-WEDGE received FDA 510(k) clearance on 2012-10-03, under 510(k) number K121287.

Who is the listed applicant for HT-WEDGE?

The FDA 510(k) record lists D.T. Davis Enterprises Ltd. T/A Hovertech Int'L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HT-WEDGE?

The FDA product code for HT-WEDGE is FNG.

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Other records listing D.T. Davis Enterprises Ltd. T/A Hovertech Int'L 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.

K102236HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P

Related Devices (Code: FNG)

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.

K041503HOVERJACK AIR PATIENT LIFT DEVICED.T. Davis Enterprises , Ltd.K940872PATIENT SUPPORT SYSTEMArylift, Inc.K935351A.C. POWER PATIENT LIFTKen KemmererK926411SAF-LIFT/SAF-KARYArjo-Century, Inc.K912769PATIENT LIFT AND TRANSPORTCentury Manufacturing Co.K905414MANGAR BOOSTERNorthfleet Management Group, Inc.

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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