Pulse Rx 2.0, Pulse Pro Rx 2.0
K-Number: K183328 · 2018-12-21
ApplicantNormaTec Industries, LP
Decision Date2018-12-21
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Pulse Rx 2.0, Pulse Pro Rx 2.0 is a medical device manufactured by NormaTec Industries, LP. It received FDA 510(k) clearance on 2018-12-21 under approval number K183328. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pulse Rx 2.0, Pulse Pro Rx 2.0?
Pulse Rx 2.0, Pulse Pro Rx 2.0 is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by NormaTec Industries, LP. The 510(k) number is K183328.
When was Pulse Rx 2.0, Pulse Pro Rx 2.0 approved by the FDA?
Pulse Rx 2.0, Pulse Pro Rx 2.0 received FDA 510(k) clearance on 2018-12-21, under approval number K183328.
What company makes Pulse Rx 2.0, Pulse Pro Rx 2.0?
Pulse Rx 2.0, Pulse Pro Rx 2.0 is manufactured by NormaTec Industries, LP.
What is the FDA product code for Pulse Rx 2.0, Pulse Pro Rx 2.0?
The FDA product code for Pulse Rx 2.0, Pulse Pro Rx 2.0 is JOW.
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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.