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FDA 510(k)

DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR

K-Number: K934287 · 1994-04-04

ApplicantDynawave, Corp.
Decision Date1994-04-04
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dynawave, Corp.. It received FDA 510(k) clearance on 1994-04-04 under 510(k) number K934287. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR?

DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR is a medical device that received FDA 510(k) clearance on 1994-04-04. The listed applicant is Dynawave, Corp.. The 510(k) number is K934287.

When did DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR receive FDA 510(k) clearance?

DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR received FDA 510(k) clearance on 1994-04-04, under 510(k) number K934287.

Who is the listed applicant for DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR?

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

What is the FDA product code for DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR?

The FDA product code for DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR is IMG.

Related Clinical Trials

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.

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Other records listing Dynawave, Corp. as applicant

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.

K811159DYNASOUND 801K791976DYNASOUND 601

Related Devices (Code: IMG)

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.

K244041Ultrasound Therapy Workstation (XMS-UET2)Xemis Medical Technology (Shenzhen) Co., Ltd.K153559OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy SystemAccelerated Care Plus (Acp)K120217SONICSTIMU COMBO THERAPEUTIC DEVICEShenzhen Dongdixin Technology Co., Ltd.K121059SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIMZimmer Medizinsystems GmbHK102524FUTURADr. Oliver Wenker, M.D., M.B.A.K111482SONICATOR PLUS 920Mettler Electronics Corp.

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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