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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 the device name listed in this FDA 510(k) record. The listed applicant is Bonutti Research, Inc.. It received FDA 510(k) clearance on 2016-11-10 under 510(k) 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. The listed applicant is Bonutti Research, Inc.. The 510(k) number is K161628.

When did JAS Pulse(TM) Ultrasonic Therapy receive FDA 510(k) clearance?

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

Who is the listed applicant for JAS Pulse(TM) Ultrasonic Therapy?

The FDA 510(k) record lists Bonutti Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: IMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.

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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