Orthosis, Sacroiliac, Soft
A soft sacroiliac orthosis is a flexible external support worn around the sacroiliac joint region of the lower back and pelvis to stabilize and reduce pain in that area. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IPW, 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
- IPW
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K811176 | TIGGES SPINAL | May 15, 1981 | Substantially Equivalent | The Tiggs Co. |
FEI Numbers
This FDA classification entry is associated with 54 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 54 registration numbers. Click on an entry to view related FDA registrations.