PQY · Class II · 21 CFR 890.5290

FDA Product Code PQY: Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

Nonthermal Pulsed Electromagnetic Energy Intended For Over-the-counter Use For The Treatment Of Pain.

Leading manufacturers include Bioelectronics Corporation.

2
Total
2
Cleared
346d
Avg days
2017
Since

FDA 510(k) Cleared Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain Devices (Product Code PQY)

2 devices
1–2 of 2
Cleared Jan 31, 2020
ActiPatch
K192234
Bioelectronics Corporation
Physical Medicine · 165d
Cleared Feb 03, 2017
ActiPatch(R)
K152432
Bioelectronics Corporation
Physical Medicine · 526d

About Product Code PQY - Regulatory Context