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FDA 510(k)

JAS Pulse(TM) Ultrasonic Therapy

K-Number: K161628 · 2016-11-10

ApplicantBonutti Research, Inc.
Decision Date2016-11-10
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

JAS Pulse(TM) Ultrasonic Therapy is a medical device manufactured by Bonutti Research, Inc.. It received FDA 510(k) clearance on 2016-11-10 under approval number K161628. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAS Pulse(TM) Ultrasonic Therapy?

JAS Pulse(TM) Ultrasonic Therapy is a medical device that received FDA 510(k) clearance on 2016-11-10. It is manufactured by Bonutti Research, Inc.. The 510(k) number is K161628.

When was JAS Pulse(TM) Ultrasonic Therapy approved by the FDA?

JAS Pulse(TM) Ultrasonic Therapy received FDA 510(k) clearance on 2016-11-10, under approval number K161628.

What company makes JAS Pulse(TM) Ultrasonic Therapy?

JAS Pulse(TM) Ultrasonic Therapy is manufactured by Bonutti Research, Inc..

What is the FDA product code for JAS Pulse(TM) Ultrasonic Therapy?

The FDA product code for JAS Pulse(TM) Ultrasonic Therapy is IMI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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