Decision Date2019-11-01
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Combo Electrotherapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K192087. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Combo Electrotherapy Device?
Combo Electrotherapy Device is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K192087.
When did Combo Electrotherapy Device receive FDA 510(k) clearance?
Combo Electrotherapy Device received FDA 510(k) clearance on 2019-11-01, under 510(k) number K192087.
Who is the listed applicant for Combo Electrotherapy Device?
The FDA 510(k) record lists Shenzhen Roundwhale Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Combo Electrotherapy Device?
The FDA product code for Combo Electrotherapy Device is NUH.
Other records listing Shenzhen Roundwhale Technology Co. , Ltd. as applicant
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Related Devices (Code: NUH)
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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.