Cleared Abbreviated

JAS Pulse(TM) Ultrasonic Therapy

K161628 · Bonutti Research, Inc. · Physical Medicine

Nov 2016

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K161628 is an FDA 510(k) clearance for the JAS Pulse(TM) Ultrasonic Therapy, a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMI), submitted by Bonutti Research, Inc. (Effingham, US). The FDA issued a Cleared decision on November 10, 2016, 150 days after receiving the submission on June 13, 2016. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K161628 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2016
Decision Date	November 10, 2016
Days to Decision	150 days
Submission Type	Abbreviated
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5300