Orthosis, Rib Fracture, Soft
A soft rib fracture orthosis is a flexible external support worn around the thorax to immobilize and protect fractured ribs during healing. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IPX, regulated under 21 CFR 890.3490, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- IPX
- Device Class
- FDA class 1
- Regulation Number
- 890.3490
- 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 |
|---|---|---|---|---|
| K823662 | RIB BELT (UNIVERSAL) | Dec 30, 1982 | Substantially Equivalent | Warm & Form, Orthopedic Materials |
| K823158 | RIB BELT (UNIVERSAL) | Nov 10, 1982 | Substantially Equivalent | Warm & Form, Orthopedic Materials |
| K803239 | SOFTGOOD PRODUCTS AND SPLINTS | Jan 09, 1981 | Substantially Equivalent | Danek Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 62 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 62 registration numbers. Click on an entry to view related FDA registrations.