DeviceClearance

Product code PQY— Physical Medicine

ActiPatch

Classification name
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Device class
Class 2
Regulation
21 CFR 890.5290
Advisory panel
Physical Medicine
Total cleared
2
First cleared
Most recent

FDA classification definition

“Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.”

— U.S. Food and Drug Administration, device classification record for product code PQY under 21 CFR 890.5290, via openFDA

Market context for product code PQY

FDA has cleared 2 devices under product code PQY between 2017 and 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PQY

Recent clearances under product code PQY

Data sourced from openFDA. This site is unofficial and independent of the FDA.