OGYILI TENS/NMES Stimulator
K-Number: K201431 · 2020-11-09
ApplicantGongguan Tutamen Metalwork Co., Ltd.
Decision Date2020-11-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
OGYILI TENS/NMES Stimulator is a medical device manufactured by Gongguan Tutamen Metalwork Co., Ltd.. It received FDA 510(k) clearance on 2020-11-09 under approval number K201431. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OGYILI TENS/NMES Stimulator?
OGYILI TENS/NMES Stimulator is a medical device that received FDA 510(k) clearance on 2020-11-09. It is manufactured by Gongguan Tutamen Metalwork Co., Ltd.. The 510(k) number is K201431.
When was OGYILI TENS/NMES Stimulator approved by the FDA?
OGYILI TENS/NMES Stimulator received FDA 510(k) clearance on 2020-11-09, under approval number K201431.
What company makes OGYILI TENS/NMES Stimulator?
OGYILI TENS/NMES Stimulator is manufactured by Gongguan Tutamen Metalwork Co., Ltd..
What is the FDA product code for OGYILI TENS/NMES Stimulator?
The FDA product code for OGYILI TENS/NMES Stimulator is GZJ.
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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.