FDA 510(k)

LOWER BODY CYCLES

K-Number: K935061 · 1994-09-16

Decision Date1994-09-16

Product CodeBXB

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

LOWER BODY CYCLES is the device name listed in this FDA 510(k) record. The listed applicant is Biodex Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-09-16 under 510(k) number K935061. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOWER BODY CYCLES?

LOWER BODY CYCLES is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Biodex Medical Systems, Inc.. The 510(k) number is K935061.

When did LOWER BODY CYCLES receive FDA 510(k) clearance?

LOWER BODY CYCLES received FDA 510(k) clearance on 1994-09-16, under 510(k) number K935061.

Who is the listed applicant for LOWER BODY CYCLES?

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

What is the FDA product code for LOWER BODY CYCLES?

The FDA product code for LOWER BODY CYCLES is BXB.

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Other records listing Biodex Medical Systems, Inc. as applicant

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Related Devices (Code: BXB)

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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.