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#
- 3003902312
- 3015892095
- 3030630899
- 3012865799
- 3007123908
- 1026765
- 3007942528
- 3006943846
- 3019387924
- 3013564718
- 3005273623
- 3037609256
- 3011816321
Source Documents#
Legacy Summary#
summary
FDA Review#
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