Orthosis, Thoracic
A thoracic orthosis is an external brace worn around the thoracic spine to provide support, restrict motion, or correct alignment of the upper back. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is IPT, 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
- IPT
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K963091 | VOLLMAN PRONE POSITIONER | Jan 09, 1997 | Substantially Equivalent | Hill-Rom, Inc. |
| K821645 | BACK SKPPORTS | Jun 11, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K812401 | CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O | Sep 14, 1981 | Substantially Equivalent | Surgical Appliance Industries, Inc. |
| K811750 | MULTITUBULAR THORACIC AIR SPLINTS | Jul 20, 1981 | Substantially Equivalent | Roger Cestac & Assoc. |
| K761128 | LATERAL TRUNK SUPPORTS | Dec 02, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 125 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 125 registration numbers. Click on an entry to view related FDA registrations.