Exerciser, Non-Measuring For Stroke Rehabilitation
The Exerciser, Non-Measuring For Stroke Rehabilitation (product code PKS) is a Class 1 physical medicine device consisting of non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion, regulated under 890.5370. Class 1 devices are subject to general controls only and are typically exempt from 510(k) requirements. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PKS
- Device Class
- FDA class 1
- Regulation Number
- 890.5370
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
Definition
Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion.
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.