Orthosis, Limb, For Back Pain
The Orthosis, Limb, For Back Pain (product code PMV) is a Class 1 physical medicine device intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg during normal household or work activities, regulated under 890.3475. Class 1 devices are subject to general controls only. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PMV
- Device Class
- FDA class 1
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K151476 | Beactive Brace | Feb 26, 2016 | Substantially Equivalent | Natures Pillows, Inc. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.