FDA product code HCJ: Device, Skin Potential Measurement
HCJ is the FDA product code for device, skin potential measurement. It is a Class II device, regulated under 21 CFR 882.1560 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under HCJ, from 2 different applicants. The average 510(k) review took 104 days (median 104).
Classification
| Field | Value |
|---|---|
| Device name | Device, Skin Potential Measurement |
| Device class | Class II |
| Regulation | 21 CFR 882.1560 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HCJ clearance
Top HCJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Share Int'L | 1 | 1983-10-27 |
| Spelson Research Laboratories, Inc. | 1 | 1983-01-21 |
Most recent HCJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832067 | Share Int'L | SHARE INT'L TDM | 1983-10-27 | 122 |
| K823194 | Spelson Research Laboratories, Inc. | SKIN GALVANOMETER | 1983-01-21 | 87 |
Recalls for HCJ devices
openFDA lists no recalls for product code HCJ.
Frequently asked questions
What is FDA product code HCJ?
HCJ is the FDA product code for device, skin potential measurement. It is a Class II device, regulated under 21 CFR 882.1560 and reviewed by the Neurology panel.
What device class is HCJ?
Class II, regulation 21 CFR 882.1560. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HCJ?
Across 2 cleared submissions the average was 104 days from receipt to decision (median 104).
Which companies have the most HCJ clearances?
Share Int'L (1); Spelson Research Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HCJ
- Run a recall and safety report across every HCJ manufacturer
- Watch product code HCJ 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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