HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
K-Number: K213655 · 2023-01-17
ApplicantHilltek, LLC
Decision Date2023-01-17
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) is a medical device manufactured by Hilltek, LLC. It received FDA 510(k) clearance on 2023-01-17 under approval number K213655. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)?
HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) is a medical device that received FDA 510(k) clearance on 2023-01-17. It is manufactured by Hilltek, LLC. The 510(k) number is K213655.
When was HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) approved by the FDA?
HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) received FDA 510(k) clearance on 2023-01-17, under approval number K213655.
What company makes HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)?
HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) is manufactured by Hilltek, LLC.
What is the FDA product code for HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)?
The FDA product code for HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) is IPF.
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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.