Joint, Hip, External Brace
A hip joint external brace component is an articulating joint unit incorporated into hip-knee-ankle-foot orthoses or hip orthoses, providing controlled hip motion while maintaining alignment and support of the hip during ambulation or positioning. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ITS, 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
- ITS
- 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 |
|---|---|---|---|---|
| K780891 | POST-OPERATIVE HIP ORTHOSIS | Jun 13, 1978 | Substantially Equivalent | Hosmer Dorrance Corp. |
FEI Numbers
This FDA classification entry is associated with 112 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 112 registration numbers. Click on an entry to view related FDA registrations.