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FDA 510(k)

SONICSTIMU COMBO THERAPEUTIC DEVICE

K-Number: K120217 · 2012-11-21

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2012-11-21
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SONICSTIMU COMBO THERAPEUTIC DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2012-11-21 under 510(k) number K120217. 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 SONICSTIMU COMBO THERAPEUTIC DEVICE?

SONICSTIMU COMBO THERAPEUTIC DEVICE is a medical device that received FDA 510(k) clearance on 2012-11-21. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K120217.

When did SONICSTIMU COMBO THERAPEUTIC DEVICE receive FDA 510(k) clearance?

SONICSTIMU COMBO THERAPEUTIC DEVICE received FDA 510(k) clearance on 2012-11-21, under 510(k) number K120217.

Who is the listed applicant for SONICSTIMU COMBO THERAPEUTIC DEVICE?

The FDA 510(k) record lists Shenzhen Dongdixin Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONICSTIMU COMBO THERAPEUTIC DEVICE?

The FDA product code for SONICSTIMU COMBO THERAPEUTIC DEVICE is IMG.

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Other records listing Shenzhen Dongdixin Technology Co., Ltd. as applicant

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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)K121059SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIMZimmer Medizinsystems GmbHK102524FUTURADr. Oliver Wenker, M.D., M.B.A.K111482SONICATOR PLUS 920Mettler Electronics Corp.K102190WINSTIMJohari Digital Healthcare , Ltd.

Official Source

View on FDA Database →

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

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