FDA product code ILI: Sling, Arm
ILI is the FDA product code for sling, arm. It is a Class I device, regulated under 21 CFR 890.3640 and reviewed by the Physical Medicine panel. FDA has cleared 21 510(k) submissions under ILI, from 14 different applicants. The average 510(k) review took 24 days (median 22). FDA has posted 5 recalls for ILI devices.
Classification
| Field | Value |
|---|---|
| Device name | Sling, Arm |
| Device class | Class I |
| Regulation | 21 CFR 890.3640 |
| 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 ILI clearance
Top ILI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 3 | 1983-06-30 |
| Maddak, Inc. | 3 | 1981-09-14 |
| Danek Medical, Inc. | 2 | 1983-01-14 |
| Warm & Form, Orthopedic Materials | 2 | 1982-12-30 |
| The Owenby Co. | 2 | 1980-07-28 |
9 more applicants have ILI clearances. See the full list in Caduvo.
Most recent ILI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K912661 | Matrix Medica, Inc. | MATRX, PYRAMID TRIANGLE BANDAGE | 1991-08-21 | 64 |
| K831549 | Fred Sammons, Inc. | ARM SLINGS | 1983-06-30 | 49 |
| K831706 | Food and Drug Service, Inc. | SATO FAMILY FIRST AID KIT | 1983-06-24 | 29 |
| K823810 | Danek Medical, Inc. | A.C. SPLINT | 1983-01-14 | 28 |
| K823808 | Danek Medical, Inc. | VARIOUS ARM SLING | 1983-01-14 | 28 |
Recalls for ILI devices
5 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-04-12.
| Year | Recalls |
|---|---|
| 2021 | 4 |
Frequently asked questions
What is FDA product code ILI?
ILI is the FDA product code for sling, arm. It is a Class I device, regulated under 21 CFR 890.3640 and reviewed by the Physical Medicine panel.
What device class is ILI?
Class I, regulation 21 CFR 890.3640. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILI?
Across 21 cleared submissions the average was 24 days from receipt to decision (median 22).
Which companies have the most ILI clearances?
Fred Sammons, Inc. (3); Maddak, Inc. (3); Danek Medical, Inc. (2); Warm & Form, Orthopedic Materials (2); The Owenby Co. (2).
Have ILI devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2021-04-12.
Next steps
- Run an FDA pathway report with predicate devices for product code ILI
- Run a recall and safety report across every ILI manufacturer
- Watch product code ILI 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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