FDA product code ILZ: Accessories, Traction
ILZ is the FDA product code for accessories, traction. It is a Class I device, regulated under 21 CFR 890.5925 and reviewed by the Physical Medicine panel. FDA has cleared 15 510(k) submissions under ILZ, from 11 different applicants. The average 510(k) review took 47 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Traction |
| Device class | Class I |
| Regulation | 21 CFR 890.5925 |
| 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 ILZ clearance
Top ILZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Warm & Form, Orthopedic Materials | 3 | 1983-03-09 |
| Biomet, Inc. | 3 | 1978-03-15 |
| Altoona Medical Supply | 1 | 1992-07-13 |
| Vibra-Trac Industries | 1 | 1989-10-16 |
| Dyna-Med | 1 | 1989-01-24 |
6 more applicants have ILZ clearances. See the full list in Caduvo.
Most recent ILZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921711 | Altoona Medical Supply | FLEXION DISTRATION SUPPORT | 1992-07-13 | 96 |
| K895382 | Vibra-Trac Industries | VIBRA-TRAC TRACTION TABLE | 1989-10-16 | 47 |
| K884340 | Dyna-Med | AMX-110, AMX-II AND AMX-III | 1989-01-24 | 102 |
| K852398 | Powlan Manufacturing Co. | VECTOR BAR SUSPENSION/TRACTION UNIT | 1985-08-12 | 67 |
| K844490 | Jerome Medical | TRACTION ACCESSORIES | 1985-02-21 | 93 |
Recalls for ILZ devices
openFDA lists no recalls for product code ILZ.
Frequently asked questions
What is FDA product code ILZ?
ILZ is the FDA product code for accessories, traction. It is a Class I device, regulated under 21 CFR 890.5925 and reviewed by the Physical Medicine panel.
What device class is ILZ?
Class I, regulation 21 CFR 890.5925. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILZ?
Across 15 cleared submissions the average was 47 days from receipt to decision (median 43).
Which companies have the most ILZ clearances?
Warm & Form, Orthopedic Materials (3); Biomet, Inc. (3); Altoona Medical Supply (1); Vibra-Trac Industries (1); Dyna-Med (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ILZ
- Run a recall and safety report across every ILZ manufacturer
- Watch product code ILZ 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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