FDA 510(k)

NormaTec Pulse and NormaTec Pulse Pro

K-Number: K160608 · 2016-04-13

Decision Date2016-04-13

Product CodeIRP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

NormaTec Pulse and NormaTec Pulse Pro is a medical device manufactured by NormaTec Industries, LP. It received FDA 510(k) clearance on 2016-04-13 under approval number K160608. 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 Pulse and NormaTec Pulse Pro?

NormaTec Pulse and NormaTec Pulse Pro is a medical device that received FDA 510(k) clearance on 2016-04-13. It is manufactured by NormaTec Industries, LP. The 510(k) number is K160608.

When was NormaTec Pulse and NormaTec Pulse Pro approved by the FDA?

NormaTec Pulse and NormaTec Pulse Pro received FDA 510(k) clearance on 2016-04-13, under approval number K160608.

What company makes NormaTec Pulse and NormaTec Pulse Pro?

NormaTec Pulse and NormaTec Pulse Pro is manufactured by NormaTec Industries, LP.

What is the FDA product code for NormaTec Pulse and NormaTec Pulse Pro?

The FDA product code for NormaTec Pulse and NormaTec Pulse Pro is IRP.

Other Devices by NormaTec Industries, LP

K161346NormaTec PCD-T and PCD-B K183169Pulse 2.0, Pulse Pro 2.0 K183328Pulse Rx 2.0, Pulse Pro Rx 2.0 K221666Normatec Go K220217Normatec 3 K240122Normatec Elite

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Related Devices (Code: 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.