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U.S. Department of Health and Human Services

Product Classification

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Device orthosis, limb, for back pain
Regulation Description Limb orthosis.
Definition Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.
Physical State The device is a leg wrap with a pressure pad.
Technical Method The device is worn around the calf of one leg and includes a pad to exert pressure against the soleus muscle.
Target Area Soleus muscle behind the lower limb.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodePMV
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Rehabilitation Devices Branch (PMDB)
Submission Type 510(K) Exempt
Regulation Number 890.3475
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    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