Normatec Go
K-Number: K221666 · 2022-07-14
ApplicantNormaTec Industries, LP
Decision Date2022-07-14
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Normatec Go is a medical device manufactured by NormaTec Industries, LP. It received FDA 510(k) clearance on 2022-07-14 under approval number K221666. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Normatec Go?
Normatec Go is a medical device that received FDA 510(k) clearance on 2022-07-14. It is manufactured by NormaTec Industries, LP. The 510(k) number is K221666.
When was Normatec Go approved by the FDA?
Normatec Go received FDA 510(k) clearance on 2022-07-14, under approval number K221666.
What company makes Normatec Go?
Normatec Go is manufactured by NormaTec Industries, LP.
What is the FDA product code for Normatec Go?
The FDA product code for Normatec Go is IRP.
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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.