Splint, Denis Brown
A Denis Brown splint is a pediatric orthotic device consisting of adjustable footplates connected by a bar, used to correct or prevent foot deformities such as clubfoot and in-toeing in infants and young children. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ITN, regulated under 21 CFR 890.3675, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- ITN
- Device Class
- FDA class 1
- Regulation Number
- 890.3675
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K071028 | VIEWMATE SYSTEM | May 01, 2007 | Substantially Equivalent | Ep Medsystems |
| K032669 | Y.E.S. POWERED WHEELCHAIR, MODEL T200 | Nov 12, 2003 | Substantially Equivalent | Yeou Eir Shuen Machinery Co., Ltd. |
| K821256 | COUNTER-ROTATION SYSTEM | Jun 23, 1982 | Substantially Equivalent | The Langer Group |
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.