Joint, Knee, External Brace
A knee joint external brace component is an articulating joint unit incorporated into knee orthoses to allow controlled flexion and extension while providing structural support and stability to the knee. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ITQ, 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
- ITQ
- 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 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K831044 | LIMITED MOTION FUNCTIONAL KNEE BRACE | Jun 24, 1983 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K831310 | BRACE C.T. | May 16, 1983 | Substantially Equivalent | Innovation Sports, Inc. |
| K823658 | DELUXE KNEE IMMOBILIZER(UNIVERSAL) | Dec 30, 1982 | Substantially Equivalent | Warm & Form, Orthopedic Materials |
| K823397 | ANATOMIC FRACTURE BRACE | Nov 29, 1982 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K823159 | DELUXE KNEE IMMOBILIZER | Nov 10, 1982 | Substantially Equivalent | Warm & Form, Orthopedic Materials |
| K812423 | NEOPRENE KNEE SUPPORT | Sep 14, 1981 | Substantially Equivalent | Surgical Appliance Industries, Inc. |
| K812094 | AIRCAST PNEUMATIC KNEE BRACE | Aug 13, 1981 | Substantially Equivalent | Aircast, Inc. |
| K811689 | CYLINDER KNEE CAST/SPLINT | Jun 25, 1981 | Substantially Equivalent | Surgical Appliance Industries, Inc. |
| K810222 | LIMB ORHTOSIS | Feb 04, 1981 | Substantially Equivalent | Medical Design & Manufacturing Corp. |
| K802673 | KNEE BRACE/STABILIZER | Nov 12, 1980 | Substantially Equivalent | Omni Scientific, Inc. |
| K780892 | FRACTURE BRACING | Jun 13, 1978 | Substantially Equivalent | Hosmer Dorrance Corp. |
| K772271 | WALKER FOLDING ADJUSTABLE | Dec 20, 1977 | Substantially Equivalent | Med Fusion Systems, Inc. |
| K772270 | SETUP WALKER OVER TOILET CONSTRUC. | Dec 20, 1977 | Substantially Equivalent | Med Fusion Systems, Inc. |
| K772269 | SETUP WALKER ADJUSTABLE | Dec 20, 1977 | Substantially Equivalent | Med Fusion Systems, Inc. |
| K772268 | DEMI-WALKER (REGULAR) | Dec 20, 1977 | Substantially Equivalent | Med Fusion Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 442 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 442 registration numbers. Click on an entry to view related FDA registrations.