Pulse 2.0, Pulse Pro 2.0
K-Number: K183169 · 2018-12-27
ApplicantNormaTec Industries, LP
Decision Date2018-12-27
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Pulse 2.0, Pulse Pro 2.0 is a medical device manufactured by NormaTec Industries, LP. It received FDA 510(k) clearance on 2018-12-27 under approval number K183169. 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 Pulse 2.0, Pulse Pro 2.0?
Pulse 2.0, Pulse Pro 2.0 is a medical device that received FDA 510(k) clearance on 2018-12-27. It is manufactured by NormaTec Industries, LP. The 510(k) number is K183169.
When was Pulse 2.0, Pulse Pro 2.0 approved by the FDA?
Pulse 2.0, Pulse Pro 2.0 received FDA 510(k) clearance on 2018-12-27, under approval number K183169.
What company makes Pulse 2.0, Pulse Pro 2.0?
Pulse 2.0, Pulse Pro 2.0 is manufactured by NormaTec Industries, LP.
What is the FDA product code for Pulse 2.0, Pulse Pro 2.0?
The FDA product code for Pulse 2.0, Pulse Pro 2.0 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.