actiTENS
K-Number: K202159 · 2020-12-22
ApplicantSublimed
Decision Date2020-12-22
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
actiTENS is a medical device manufactured by Sublimed. It received FDA 510(k) clearance on 2020-12-22 under approval number K202159. 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 actiTENS?
actiTENS is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Sublimed. The 510(k) number is K202159.
When was actiTENS approved by the FDA?
actiTENS received FDA 510(k) clearance on 2020-12-22, under approval number K202159.
What company makes actiTENS?
actiTENS is manufactured by Sublimed.
What is the FDA product code for actiTENS?
The FDA product code for actiTENS 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.