FDA product code ILW: Adaptor, Grooming
ILW is the FDA product code for adaptor, grooming. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel. FDA has cleared 7 510(k) submissions under ILW. The average 510(k) review took 25 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Grooming |
| Device class | Class I |
| Regulation | 21 CFR 890.5050 |
| 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 ILW clearance
Top ILW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 7 | 1982-12-28 |
Most recent ILW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823632 | Fred Sammons, Inc. | LONG HANDLED FOLDING HAIRBRUSH | 1982-12-28 | 22 |
| K810457 | Fred Sammons, Inc. | GROOMING ADAPTORS | 1981-03-04 | 13 |
| K781197 | Fred Sammons, Inc. | STICK, UTILITY | 1978-07-31 | 17 |
| K781200 | Fred Sammons, Inc. | NAIL CLIPPERS, ONE-HANDED | 1978-07-31 | 17 |
| K761123 | Fred Sammons, Inc. | ELECTRIC RAZOR HOLDER | 1976-12-02 | 13 |
Recalls for ILW devices
openFDA lists no recalls for product code ILW.
Frequently asked questions
What is FDA product code ILW?
ILW is the FDA product code for adaptor, grooming. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel.
What device class is ILW?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILW?
Across 7 cleared submissions the average was 25 days from receipt to decision (median 17).
Which companies have the most ILW clearances?
Fred Sammons, Inc. (7).
Next steps
- Run an FDA pathway report with predicate devices for product code ILW
- Run a recall and safety report across every ILW manufacturer
- Watch product code ILW 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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