Replies to post #156285 on Bioelectronics Corp (BIEL)

[seven-up]

1st it's a stickie because I wanted to stick the post, simple.

FDA product classification for Actipatch and the new clearance will be in this classification

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

Regulation Description Shortwave diathermy.

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

Physical State Nonthermal shortwave therapy devices which include applicators applied to the body.

Technical Method Uses pulsed electromagnetic energy at 13.56 MHz or 27.12 MHz delivered treatment.

Target Area To be applied over body areas and joints such as the knee and ankle; however, the device should not be applied directly over areas with active implantables.

Regulation Medical Specialty Physical Medicine

Review Panel Physical Medicine

Product Code PQY

Premarket Review Office of Device Evaluation (ODE)

Division of Neurological and Physical Medicine Devices (DNPMD)

Physical Medicine and Rehabilitation Devices Branch (PMDB)

Submission Type 510(k)

Regulation Number 890.5290

Device Class 2

Total Product Life Cycle (TPLC) TPLC Product Code Report

GMP Exempt? No

Summary Malfunction

Reporting Ineligible

Implanted Device? No

Life-Sustain/Support Device? No

Third Party Review Not Third Party Eligible
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Page Last Updated: 10/29/2018



https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5197