FDA product code INE: Sling, Overhead Suspension, Wheelchair
INE is the FDA product code for sling, overhead suspension, wheelchair. It is a Class I device, regulated under 21 CFR 890.3910 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under INE. The average 510(k) review took 70 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Sling, Overhead Suspension, Wheelchair |
| Device class | Class I |
| Regulation | 21 CFR 890.3910 |
| 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 INE clearance
Top INE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Alignment Systems | 1 | 1989-01-24 |
Most recent INE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884787 | Medical Alignment Systems | ACCULITE-PPL 5 | 1989-01-24 | 70 |
Recalls for INE devices
openFDA lists no recalls for product code INE.
Frequently asked questions
What is FDA product code INE?
INE is the FDA product code for sling, overhead suspension, wheelchair. It is a Class I device, regulated under 21 CFR 890.3910 and reviewed by the Physical Medicine panel.
What device class is INE?
Class I, regulation 21 CFR 890.3910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code INE?
Across 1 cleared submissions the average was 70 days from receipt to decision (median 70).
Which companies have the most INE clearances?
Medical Alignment Systems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code INE
- Run a recall and safety report across every INE manufacturer
- Watch product code INE 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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