FDA product code ITQ: Joint, Knee, External Brace
ITQ is the FDA product code for joint, knee, external brace. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 15 510(k) submissions under ITQ, from 9 different applicants. The average 510(k) review took 20 days (median 16). FDA has posted 12 recalls for ITQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Joint, Knee, External Brace |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every ITQ clearance
Top ITQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med Fusion Systems, Inc. | 4 | 1977-12-20 |
| Orthopedic Systems, Inc. | 2 | 1983-06-24 |
| Warm & Form, Orthopedic Materials | 2 | 1982-12-30 |
| Surgical Appliance Industries, Inc. | 2 | 1981-09-14 |
| Innovation Sports, Inc. | 1 | 1983-05-16 |
4 more applicants have ITQ clearances. See the full list in Caduvo.
Most recent ITQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831044 | Orthopedic Systems, Inc. | LIMITED MOTION FUNCTIONAL KNEE BRACE | 1983-06-24 | 85 |
| K831310 | Innovation Sports, Inc. | BRACE C.T. | 1983-05-16 | 24 |
| K823658 | Warm & Form, Orthopedic Materials | DELUXE KNEE IMMOBILIZER(UNIVERSAL) | 1982-12-30 | 24 |
| K823397 | Orthopedic Systems, Inc. | ANATOMIC FRACTURE BRACE | 1982-11-29 | 17 |
| K823159 | Warm & Form, Orthopedic Materials | DELUXE KNEE IMMOBILIZER | 1982-11-10 | 16 |
Recalls for ITQ devices
12 product recalls in 6 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-06-18.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code ITQ?
ITQ is the FDA product code for joint, knee, external brace. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is ITQ?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ITQ?
Across 15 cleared submissions the average was 20 days from receipt to decision (median 16).
Which companies have the most ITQ clearances?
Med Fusion Systems, Inc. (4); Orthopedic Systems, Inc. (2); Warm & Form, Orthopedic Materials (2); Surgical Appliance Industries, Inc. (2); Innovation Sports, Inc. (1).
Have ITQ devices been recalled?
Yes: 12 product recalls across 6 recall events; the most recent began 2020-06-18.
Next steps
- Run an FDA pathway report with predicate devices for product code ITQ
- Run a recall and safety report across every ITQ manufacturer
- Watch product code ITQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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