TENS & PMS
K-Number: K201354 · 2020-12-11
Decision Date2020-12-11
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
TENS & PMS is a medical device manufactured by Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2020-12-11 under approval number K201354. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TENS & PMS?
TENS & PMS is a medical device that received FDA 510(k) clearance on 2020-12-11. It is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K201354.
When was TENS & PMS approved by the FDA?
TENS & PMS received FDA 510(k) clearance on 2020-12-11, under approval number K201354.
What company makes TENS & PMS?
TENS & PMS is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited.
What is the FDA product code for TENS & PMS?
The FDA product code for TENS & PMS is NGX.
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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.