FDA product code ILQ: System, Communication, Powered
ILQ is the FDA product code for system, communication, powered. It is a Class II device, regulated under 21 CFR 890.3710 and reviewed by the Physical Medicine panel. FDA has cleared 38 510(k) submissions under ILQ, from 26 different applicants. The average 510(k) review took 88 days (median 36). FDA has posted 19 recalls for ILQ devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Communication, Powered |
| Device class | Class II |
| Regulation | 21 CFR 890.3710 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
510(k) clearances per year for ILQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 104 |
Compare with all 510(k) review times · Search every ILQ clearance
Top ILQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Prentke Romich Co. | 4 | 1993-03-29 |
| Zygo Industries, Inc. | 4 | 1993-03-04 |
| Med Labs, Inc. | 3 | 1994-02-17 |
| Possum, Inc. | 3 | 1977-01-12 |
| Companion Products Intl. | 2 | 1991-03-07 |
21 more applicants have ILQ clearances. See the full list in Caduvo.
Most recent ILQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162817 | Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. | Noddle(TM) | 2017-01-18 | 104 |
| K943035 | Mathews Assoc., Inc. | P.A.T. SYSTEM | 1994-10-04 | 99 |
| K930044 | Health Care Keyboard Co., Inc. | COMFORT KEYBOARD SYSTEM | 1994-07-14 | 555 |
| K931855 | Zygo Corp. | LIGHTWRITER | 1994-05-10 | 392 |
| K935244 | R & D Batteries, Inc. | R & D BATTERIES, INC. PART NUMBER 5113 | 1994-04-19 | 169 |
Recalls for ILQ devices
19 product recalls in 16 recall events; 9 initiated in the last five years and 5 still open. Most recent: 2026-07-08.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2021 | 2 |
| 2022 | 4 |
| 2023 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code ILQ?
ILQ is the FDA product code for system, communication, powered. It is a Class II device, regulated under 21 CFR 890.3710 and reviewed by the Physical Medicine panel.
What device class is ILQ?
Class II, regulation 21 CFR 890.3710. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILQ?
Across 38 cleared submissions the average was 88 days from receipt to decision (median 36).
Which companies have the most ILQ clearances?
Prentke Romich Co. (4); Zygo Industries, Inc. (4); Med Labs, Inc. (3); Possum, Inc. (3); Companion Products Intl. (2).
Have ILQ devices been recalled?
Yes: 19 product recalls across 16 recall events; the most recent began 2026-07-08.
Next steps
- Run an FDA pathway report with predicate devices for product code ILQ
- Run a recall and safety report across every ILQ manufacturer
- Watch product code ILQ 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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