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FDA 510(k)

USHIFU STEPPER

K-Number: K080970 · 2008-06-11

ApplicantUshifu Development Company, LLC
Decision Date2008-06-11
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

USHIFU STEPPER is the device name listed in this FDA 510(k) record. The listed applicant is Ushifu Development Company, LLC. It received FDA 510(k) clearance on 2008-06-11 under 510(k) number K080970. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the USHIFU STEPPER?

USHIFU STEPPER is a medical device that received FDA 510(k) clearance on 2008-06-11. The listed applicant is Ushifu Development Company, LLC. The 510(k) number is K080970.

When did USHIFU STEPPER receive FDA 510(k) clearance?

USHIFU STEPPER received FDA 510(k) clearance on 2008-06-11, under 510(k) number K080970.

Who is the listed applicant for USHIFU STEPPER?

The FDA 510(k) record lists Ushifu Development Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for USHIFU STEPPER?

The FDA product code for USHIFU STEPPER is ITX.

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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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