Exercise Bicycle

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K926287 ↗

FDA Product Code

ISD

Device Class

Class II

Regulation

21 CFR Part 890.5360

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Jeltrode

  Class II

  FDA 510(k) K861956 Active Cleared 26 Jun 1986

• Am Tm Syrgical Drapes

  Class II

  FDA 510(k) K882643 Active Cleared 3 Mar 1989

• Endomed CV405

  Class II

  FDA 510(k) K880699 Active Cleared 2 May 1988

• Computerized Testing and Exercise Systems

  Class I

  FDA 510(k) K926313 Active Cleared 4 Feb 1994

• Monotrode Cutaneous Electrode

  Class II

  FDA 510(k) K915864 Active Cleared 21 Jul 1993

• Model T11 Fluidotherapy Unit

  Class II

  FDA 510(k) K896817 Active Cleared 18 Jan 1991

See all devices from Henley Intl. →

• What is the Henley Exercise Bicycle designed for?

  The Henley Exercise Bicycle is a Measuring Exerciser (FDA classification ISD) specifically designed for physical therapy and rehabilitation. It provides controlled, low-impact cardiovascular exercise to help patients improve mobility, strength, and endurance. The device is particularly useful for those recovering from injury or managing chronic conditions, as it incorporates instrumentation to measure physiological parameters like pulse rate. This data aids clinicians in assessing progress and tailoring treatment plans.

• Is the Henley Exercise Bicycle reusable or single-use?

  The Henley Exercise Bicycle is a reusable device. It is not intended for single-use and is explicitly classified as non-sterile, meaning it is meant for repeated use in clinical physical therapy environments. Sterility is not required for this device, as outlined in the regulatory data.

• What regulatory approvals does the Henley Exercise Bicycle hold?

  The Henley Exercise Bicycle holds a Traditional 510(k) clearance (K926287) under the Physical Medicine advisory committee. It is classified under FDA regulation 890.5360 and is determined to be substantially equivalent to a predicate device. The device is listed under multiple FDA registration numbers, reflecting its inclusion in various product listings.

• Does the Henley Exercise Bicycle have MRI safety requirements?

  The regulatory data for the Henley Exercise Bicycle does not specify any MRI safety requirements. Clinicians should confirm compatibility with their facility’s MRI protocols before use, as this information is not provided in the available documentation.

• Are there different sizes or models of the Henley Exercise Bicycle?

  The provided regulatory data does not include specific details about sizing or multiple models of the Henley Exercise Bicycle. If size variations or specific model references are required for clinical or facility needs, additional manufacturer documentation or inquiries should be consulted.