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U.S. Department of Health and Human Services

Product Classification

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Device exerciser, non-measuring for stroke rehabilitation
Regulation Description Nonmeasuring exercise equipment.
Definition Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion.
Physical State The device may consist of two arm frames mechanically linked that allow the user to use the unaffected arm to move the affect/weak arm. The device may also consist of a single frame that is used by both upper extremities simultaneously with the unaffected upper extremity facilitating movement of the affected upper extremity.
Technical Method These devices are not powered exercise devices in that they do not provide movement to the user¿s upper limbs. The movement of the user's upper limbs is entirely governed by the user.
Target Area Upper extremities
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodePKS
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(K) Exempt
Regulation Number 890.5370
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible