FDA product code ILP: System, Communication, Non-Powered
ILP is the FDA product code for system, communication, non-powered. It is a Class I device, regulated under 21 CFR 890.3700 and reviewed by the Physical Medicine panel. FDA has cleared 21 510(k) submissions under ILP, from 4 different applicants. The average 510(k) review took 23 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | System, Communication, Non-Powered |
| Device class | Class I |
| Regulation | 21 CFR 890.3700 |
| 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 ILP clearance
Top ILP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 18 | 1983-06-08 |
| Mina Manufacturers, Inc. | 1 | 1985-03-08 |
| Joseph A. Resnick | 1 | 1984-03-22 |
| Possum, Inc. | 1 | 1977-01-12 |
Most recent ILP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844890 | Mina Manufacturers, Inc. | TELL ME TAGS - NONPOWERED COMMUNICATION SYS | 1985-03-08 | 81 |
| K840112 | Joseph A. Resnick | SPEECH TEACHER | 1984-03-22 | 73 |
| K831546 | Fred Sammons, Inc. | ADAPTIVE PENS & LAP DESK | 1983-06-08 | 27 |
| K823608 | Fred Sammons, Inc. | PICTURES & WORD IDENTIFICATION CVA PAT | 1982-12-30 | 24 |
| K823612 | Fred Sammons, Inc. | ADJ. WOODEN BOARD FOR WRITING | 1982-12-30 | 24 |
Recalls for ILP devices
openFDA lists no recalls for product code ILP.
Frequently asked questions
What is FDA product code ILP?
ILP is the FDA product code for system, communication, non-powered. It is a Class I device, regulated under 21 CFR 890.3700 and reviewed by the Physical Medicine panel.
What device class is ILP?
Class I, regulation 21 CFR 890.3700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILP?
Across 21 cleared submissions the average was 23 days from receipt to decision (median 16).
Which companies have the most ILP clearances?
Fred Sammons, Inc. (18); Mina Manufacturers, Inc. (1); Joseph A. Resnick (1); Possum, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ILP
- Run a recall and safety report across every ILP manufacturer
- Watch product code ILP 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