510(k) K151476
K151476 is an FDA 510(k) premarket notification submitted by Natures Pillows, Inc. for the device "Beactive Brace". The FDA issued a decision of Substantially Equivalent on February 26, 2016. The device falls under product code PMV (Orthosis, Limb, For Back Pain), a Class I device regulated under 21 CFR 890.3475.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2016
- Date Received
- June 2, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Limb, For Back Pain
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type
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.