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FDA 510(k)

QUADTRAX

K-Number: K935201 · 1994-05-06

ApplicantBody Bike, Inc.
Decision Date1994-05-06
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

QUADTRAX is the device name listed in this FDA 510(k) record. The listed applicant is Body Bike, Inc.. It received FDA 510(k) clearance on 1994-05-06 under 510(k) number K935201. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the QUADTRAX?

QUADTRAX is a medical device that received FDA 510(k) clearance on 1994-05-06. The listed applicant is Body Bike, Inc.. The 510(k) number is K935201.

When did QUADTRAX receive FDA 510(k) clearance?

QUADTRAX received FDA 510(k) clearance on 1994-05-06, under 510(k) number K935201.

Who is the listed applicant for QUADTRAX?

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

What is the FDA product code for QUADTRAX?

The FDA product code for QUADTRAX is ITI.

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Related Devices (Code: ITI)

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

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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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