FDA product code ILH: Splint, Hand, And Components
ILH is the FDA product code for splint, hand, and components. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 36 510(k) submissions under ILH, from 10 different applicants. The average 510(k) review took 21 days (median 18). FDA has posted 1 recall for ILH devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Splint, Hand, And Components |
| 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 ILH clearance
Top ILH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 21 | 1983-06-27 |
| Conco Medical Co. | 5 | 1982-04-08 |
| Warm & Form, Orthopedic Materials | 2 | 1982-12-30 |
| Maddak, Inc. | 2 | 1981-09-25 |
| Vermont Wood Industries, Inc. | 1 | 1983-08-01 |
5 more applicants have ILH clearances. See the full list in Caduvo.
Most recent ILH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832144 | Vermont Wood Industries, Inc. | SPLINT WOOD | 1983-08-01 | 32 |
| K831548 | Fred Sammons, Inc. | SPLINTS | 1983-06-27 | 46 |
| K823644 | Fred Sammons, Inc. | FINGER FLEXION SPLINT | 1983-01-21 | 46 |
| K823647 | Fred Sammons, Inc. | FINGER EXTENSION SPLINT | 1983-01-21 | 46 |
| K823666 | Warm & Form, Orthopedic Materials | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | 1982-12-30 | 24 |
Recalls for ILH devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-08-18.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code ILH?
ILH is the FDA product code for splint, hand, and components. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is ILH?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILH?
Across 36 cleared submissions the average was 21 days from receipt to decision (median 18).
Which companies have the most ILH clearances?
Fred Sammons, Inc. (21); Conco Medical Co. (5); Warm & Form, Orthopedic Materials (2); Maddak, Inc. (2); Vermont Wood Industries, Inc. (1).
Have ILH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-08-18.
Next steps
- Run an FDA pathway report with predicate devices for product code ILH
- Run a recall and safety report across every ILH manufacturer
- Watch product code ILH 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