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FDA 510(k)

WINSTIM

K-Number: K102190 · 2011-03-17

ApplicantJohari Digital Healthcare , Ltd.
Decision Date2011-03-17
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WINSTIM is the device name listed in this FDA 510(k) record. The listed applicant is Johari Digital Healthcare , Ltd.. It received FDA 510(k) clearance on 2011-03-17 under 510(k) number K102190. 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 WINSTIM?

WINSTIM is a medical device that received FDA 510(k) clearance on 2011-03-17. The listed applicant is Johari Digital Healthcare , Ltd.. The 510(k) number is K102190.

When did WINSTIM receive FDA 510(k) clearance?

WINSTIM received FDA 510(k) clearance on 2011-03-17, under 510(k) number K102190.

Who is the listed applicant for WINSTIM?

The FDA 510(k) record lists Johari Digital Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WINSTIM?

The FDA product code for WINSTIM is IMG.

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Other records listing Johari Digital Healthcare , 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)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

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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