Stirrup, External Brace Component
A stirrup external brace component is a structural element of an orthotic brace that connects the upright brace frame to the shoe or footwear, transmitting forces and providing mediolateral ankle stability. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ITC, regulated under 21 CFR 890.3410, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- ITC
- Device Class
- FDA class 1
- Regulation Number
- 890.3410
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.