Joint, Ankle, External Brace
An ankle joint external brace component is an articulating joint unit incorporated into ankle-foot orthoses that allows controlled dorsiflexion and plantarflexion while providing mediolateral ankle stability, used in the management of foot drop and ankle instability. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ITW, regulated under 21 CFR 890.3475, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- ITW
- Device Class
- FDA class 1
- Regulation Number
- 890.3475
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K821639 | ANKLE FOOT ORTHOSIS | Jun 11, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 447 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 447 registration numbers. Click on an entry to view related FDA registrations.