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Haverich Orthopaedic Cycles
Haverich Ortho-Sport (Usa)
Summary: Haverich Orthopaedic Cycles are devices used in orthopedic rehabilitation to aid in joint mobility and muscle strengthening. They are typically used by physical therapists and rehabilitation specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K932795 ↗
Decision Date ?
July 22, 1993
Product Code ?
IOR
Device Class ?
Class 1
Evidence ?
0 studies
The Haverich Orthopaedic Cycles were cleared through the FDA 510(k) pathway on July 22, 1993. Manufactured by Haverich Ortho-Sport (USA), this device is classified as Class 1 under product code IOR.
What It Is
The Haverich Orthopaedic Cycles are therapeutic devices designed to assist in the rehabilitation of patients with joint and muscle impairments. These cycles provide low-impact exercise options to improve range of motion, enhance muscle strength, and support recovery in orthopedic conditions. They are often adjustable to accommodate different patient sizes and capabilities, making them versatile for various rehabilitation needs.
FDA-Cleared Indications
- Rehabilitation of the musculoskeletal system.
Clinical Applications
- Controlled exercise during orthopedic rehabilitation.
- Range-of-motion training for affected joints.
- Progressive muscle-strengthening therapy.
- Supervised rehabilitation after orthopedic injury or surgery when prescribed by a clinician.
Practical Considerations
- A clinician or therapist should select and adjust the cycle for the patient’s size, mobility, joint range of motion and rehabilitation goals.
- Resistance and exercise intensity should be increased gradually and stopped if the patient develops significant pain, swelling, dizziness or other concerning symptoms.
- The device is intended for supervised therapeutic exercise; it does not replace evaluation or treatment of the underlying orthopedic condition.
- The FDA record identifies the device as a Class I product under product code IOR. The available record does not provide specific MRI-safety labeling, so it should not be taken into an MRI environment unless the exact model has been confirmed as MR Safe or MR Conditional.
- Inspect the cycle before use and follow the manufacturer’s instructions for positioning, cleaning, maintenance and any weight or adjustment limits.
Frequently Asked Questions
What is Haverich Orthopaedic Cycles used for?
They are used for orthopedic rehabilitation to improve joint mobility and muscle strength.
What specialties typically use this device?
Physical therapists and rehabilitation specialists commonly use these devices.
What are the FDA-cleared indications?
They are indicated for use in patients needing rehabilitation of the musculoskeletal system, such as those recovering from surgeries or managing chronic joint conditions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.