FDA product code PQY: Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
PQY is the FDA product code for nonthermal shortwave therapy device indicated for over the counter use for the treatment of pain. It is a Class II device, regulated under 21 CFR 890.5290 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under PQY. The average 510(k) review took 346 days (median 346).
Definition
Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.
Classification
| Field | Value |
|---|---|
| Device name | Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain |
| Device class | Class II |
| Regulation | 21 CFR 890.5290 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
510(k) clearances per year for PQY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 526 |
| 2020 | 1 | 165 |
Compare with all 510(k) review times · Search every PQY clearance
Top PQY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bioelectronics Corporation | 2 | 2020-01-31 |
Most recent PQY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192234 | Bioelectronics Corporation | ActiPatch | 2020-01-31 | 165 |
| K152432 | Bioelectronics Corporation | ActiPatch(R) | 2017-02-03 | 526 |
Recalls for PQY devices
openFDA lists no recalls for product code PQY.
Frequently asked questions
What is FDA product code PQY?
PQY is the FDA product code for nonthermal shortwave therapy device indicated for over the counter use for the treatment of pain. It is a Class II device, regulated under 21 CFR 890.5290 and reviewed by the Physical Medicine panel.
What device class is PQY?
Class II, regulation 21 CFR 890.5290. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQY?
Across 2 cleared submissions the average was 346 days from receipt to decision (median 346).
Which companies have the most PQY clearances?
Bioelectronics Corporation (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PQY
- Run a recall and safety report across every PQY manufacturer
- Watch product code PQY 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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