510(k) K151476

Device
Beactive Brace
Applicant
NATURES PILLOWS, INC.
510(k) number
K151476
Product code
PMV  
Decision
Substantially Equivalent (SESE)
Decision date
2016-02-26
Date received
2015-06-02
Regulation
890.3475
Classification name
Orthosis, Limb, For Back Pain
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM McALISTER
Address
2607 Interplex Dr. Trevose PA US 19053 19053

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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