Comfortpro
K-Number: K212438 · 2021-12-07
ApplicantThai Rubber Industry Company Limited
Decision Date2021-12-07
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Comfortpro is a medical device manufactured by Thai Rubber Industry Company Limited. It received FDA 510(k) clearance on 2021-12-07 under approval number K212438. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Comfortpro?
Comfortpro is a medical device that received FDA 510(k) clearance on 2021-12-07. It is manufactured by Thai Rubber Industry Company Limited. The 510(k) number is K212438.
When was Comfortpro approved by the FDA?
Comfortpro received FDA 510(k) clearance on 2021-12-07, under approval number K212438.
What company makes Comfortpro?
Comfortpro is manufactured by Thai Rubber Industry Company Limited.
What is the FDA product code for Comfortpro?
The FDA product code for Comfortpro is LYY.
Other Devices by Thai Rubber Industry Company 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.