TENS & PMS (Model: SM9126)
K-Number: K220150 · 2022-02-17
Decision Date2022-02-17
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
TENS & PMS (Model: SM9126) is a medical device manufactured by Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2022-02-17 under approval number K220150. 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 TENS & PMS (Model: SM9126)?
TENS & PMS (Model: SM9126) is a medical device that received FDA 510(k) clearance on 2022-02-17. It is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K220150.
When was TENS & PMS (Model: SM9126) approved by the FDA?
TENS & PMS (Model: SM9126) received FDA 510(k) clearance on 2022-02-17, under approval number K220150.
What company makes TENS & PMS (Model: SM9126)?
TENS & PMS (Model: SM9126) is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited.
What is the FDA product code for TENS & PMS (Model: SM9126)?
The FDA product code for TENS & PMS (Model: SM9126) is NUH.
Other Devices by Hong Qiangxing (Shenzhen) Electronics Limited
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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.