510(k) K192234

Device

ActiPatch

Applicant

Bioelectronics Corporation

510(k) number

K192234

Product code

PQY

Decision

Substantially Equivalent (SESE)

Decision date

2020-01-31

Date received

2019-08-19

Regulation

890.5290

Classification name

Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

Medical specialty

Physical Medicine

Review panel

Physical Medicine

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No