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FDA 510(k)

THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010

K-Number: K050701 · 2005-04-01

ApplicantBionix Development Corp.
Decision Date2005-04-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 2005-04-01 under 510(k) number K050701. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010?

THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 is a medical device that received FDA 510(k) clearance on 2005-04-01. The listed applicant is Bionix Development Corp.. The 510(k) number is K050701.

When did THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 receive FDA 510(k) clearance?

THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 received FDA 510(k) clearance on 2005-04-01, under 510(k) number K050701.

Who is the listed applicant for THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010?

The FDA 510(k) record lists Bionix Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010?

The FDA product code for THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 is IYE.

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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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