FDA product code GWI: Discriminator, Two-Point
GWI is the FDA product code for discriminator, two-point. It is a Class I device, regulated under 21 CFR 882.1200 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under GWI, from 2 different applicants. The average 510(k) review took 103 days (median 103).
Classification
| Field | Value |
|---|---|
| Device name | Discriminator, Two-Point |
| Device class | Class I |
| Regulation | 21 CFR 882.1200 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every GWI clearance
Top GWI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jcm Management & Planning Co. | 1 | 1995-03-08 |
| Orthopedic Systems, Inc. | 1 | 1987-11-06 |
Most recent GWI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944234 | Jcm Management & Planning Co. | TCD OR TCD NEUROPATHY STAR | 1995-03-08 | 189 |
| K874300 | Orthopedic Systems, Inc. | AESTHESIOMETER | 1987-11-06 | 17 |
Recalls for GWI devices
openFDA lists no recalls for product code GWI.
Frequently asked questions
What is FDA product code GWI?
GWI is the FDA product code for discriminator, two-point. It is a Class I device, regulated under 21 CFR 882.1200 and reviewed by the Neurology panel.
What device class is GWI?
Class I, regulation 21 CFR 882.1200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GWI?
Across 2 cleared submissions the average was 103 days from receipt to decision (median 103).
Which companies have the most GWI clearances?
Jcm Management & Planning Co. (1); Orthopedic Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GWI
- Run a recall and safety report across every GWI manufacturer
- Watch product code GWI 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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