FDA product code ITJ: Walker, Mechanical
ITJ is the FDA product code for walker, mechanical. It is a Class I device, regulated under 21 CFR 890.3825 and reviewed by the Physical Medicine panel. FDA has cleared 14 510(k) submissions under ITJ, from 13 different applicants. The average 510(k) review took 23 days (median 19). FDA has posted 27 recalls for ITJ devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Walker, Mechanical |
| Device class | Class I |
| Regulation | 21 CFR 890.3825 |
| 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 ITJ clearance
Top ITJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Maddak, Inc. | 2 | 1979-04-03 |
| Kaye Products, Inc. | 1 | 1983-11-29 |
| Convaid Products, Inc. | 1 | 1983-10-27 |
| Meta-Morris | 1 | 1983-05-25 |
| Lic-Orthion | 1 | 1983-04-05 |
8 more applicants have ITJ clearances. See the full list in Caduvo.
Most recent ITJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833869 | Kaye Products, Inc. | CHILD'S WALKER | 1983-11-29 | 21 |
| K833195 | Convaid Products, Inc. | UMBRELLA WALKER | 1983-10-27 | 38 |
| K830784 | Meta-Morris | WALK N ROLL | 1983-05-25 | 75 |
| K830848 | Lic-Orthion | RESI-WALKER | 1983-04-05 | 19 |
| K823105 | Orthion Corp. | RESI-WALKER | 1982-11-05 | 16 |
Recalls for ITJ devices
27 product recalls in 22 recall events; 8 initiated in the last five years and 10 still open. Most recent: 2024-08-26.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 5 |
Frequently asked questions
What is FDA product code ITJ?
ITJ is the FDA product code for walker, mechanical. It is a Class I device, regulated under 21 CFR 890.3825 and reviewed by the Physical Medicine panel.
What device class is ITJ?
Class I, regulation 21 CFR 890.3825. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ITJ?
Across 14 cleared submissions the average was 23 days from receipt to decision (median 19).
Which companies have the most ITJ clearances?
Maddak, Inc. (2); Kaye Products, Inc. (1); Convaid Products, Inc. (1); Meta-Morris (1); Lic-Orthion (1).
Have ITJ devices been recalled?
Yes: 27 product recalls across 22 recall events; the most recent began 2024-08-26.
Next steps
- Run an FDA pathway report with predicate devices for product code ITJ
- Run a recall and safety report across every ITJ manufacturer
- Watch product code ITJ 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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