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

FDA Device Classification

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