FDA product code ILE: Sling, Arm, Overhead Supported
ILE is the FDA product code for sling, arm, overhead supported. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 3 510(k) submissions under ILE, from 3 different applicants. The average 510(k) review took 21 days (median 19).
Classification
| Field | Value |
|---|---|
| Device name | Sling, Arm, Overhead Supported |
| 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 ILE clearance
Top ILE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lic-Orthion | 1 | 1983-04-05 |
| Danek Medical, Inc. | 1 | 1983-01-14 |
| Orthion Corp. | 1 | 1982-11-05 |
Most recent ILE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830842 | Lic-Orthion | OB HELP ARM | 1983-04-05 | 19 |
| K823811 | Danek Medical, Inc. | OVERHEAD ARM SLINGS | 1983-01-14 | 28 |
| K823152 | Orthion Corp. | OB HELP ARM | 1982-11-05 | 16 |
Recalls for ILE devices
openFDA lists no recalls for product code ILE.
Frequently asked questions
What is FDA product code ILE?
ILE is the FDA product code for sling, arm, overhead supported. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is ILE?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILE?
Across 3 cleared submissions the average was 21 days from receipt to decision (median 19).
Which companies have the most ILE clearances?
Lic-Orthion (1); Danek Medical, Inc. (1); Orthion Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ILE
- Run a recall and safety report across every ILE manufacturer
- Watch product code ILE 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.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times