Product Code: IQE
FDA class 1
21 CFR 890.3490
Orthosis, Lumbar
Physical Medicine
A lumbar orthosis is an external brace fitted to the lower back to provide support, restrict motion, and reduce pain associated with lumbar spine conditions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQE, regulated under 21 CFR 890.3490, within the Physical Medicine medical specialty. This device is GMP exempt.
510(k)s
4
FEI Numbers
323
Registration Numbers
323
Unique Applicants
4
Years Active
1
Basic Information
- Product Code
- IQE
- Device Class
- FDA class 1
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
✓
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K821682 | TRUNCAL ORTHOSIS | Jun 24, 1982 | Substantially Equivalent | Surgical Appliance Industries, Inc. |
| K820051 | OBUS FORME ORTHOPEDIC BRACE, UPRIGHT | Jan 29, 1982 | Substantially Equivalent | Obus Forme, Ltd. |
| K812719 | PROSANA BELT | Oct 06, 1981 | Substantially Equivalent | Bandwagon, Inc. |
| K810450 | TRUNCAL ORTHOSIS | Mar 04, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 323 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 323 registration numbers. Click on an entry to view related FDA registrations.