PQY — Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain Class II

FDA Device Classification

FDA product code PQY covers "Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain", a Class II medical device regulated under 21 CFR 890.5290. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
PQY
Device Class
Class II
Regulation Number
890.5290
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K192234bioelectronics corporationActiPatchJanuary 31, 2020
K152432bioelectronics corporationActiPatch(R)February 3, 2017