The following data is part of a premarket notification filed by Natures Pillows, Inc. with the FDA for Beactive Brace.
| Device ID | K151476 |
| 510k Number | K151476 |
| Device Name: | Beactive Brace |
| Classification | Orthosis, Limb, For Back Pain |
| Applicant | NATURES PILLOWS, INC. 2607 INTERPLEX DRIVE Trevose, PA 19053 |
| Contact | William Mcalister |
| Correspondent | Thomas C. Knott BENJAMIN L. ENGLAND AND ASSOCIATES, LLC 810 LANDMARK DRIVE, SUITE 126 Glen Burnie, MD 21061 |
| Product Code | PMV |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-02 |
| Decision Date | 2016-02-26 |
| Summary: | summary |