FDA 510(k)

NormaTec PCD-T and PCD-B

K-Number: K161346 · 2016-06-15

Decision Date2016-06-15

Product CodeJOW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NormaTec PCD-T and PCD-B is a medical device manufactured by NormaTec Industries, LP. It received FDA 510(k) clearance on 2016-06-15 under approval number K161346. 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 NormaTec PCD-T and PCD-B?

NormaTec PCD-T and PCD-B is a medical device that received FDA 510(k) clearance on 2016-06-15. It is manufactured by NormaTec Industries, LP. The 510(k) number is K161346.

When was NormaTec PCD-T and PCD-B approved by the FDA?

NormaTec PCD-T and PCD-B received FDA 510(k) clearance on 2016-06-15, under approval number K161346.

What company makes NormaTec PCD-T and PCD-B?

NormaTec PCD-T and PCD-B is manufactured by NormaTec Industries, LP.

What is the FDA product code for NormaTec PCD-T and PCD-B?

The FDA product code for NormaTec PCD-T and PCD-B is JOW.

Other Devices by NormaTec Industries, LP

K160608NormaTec Pulse and NormaTec Pulse Pro K183169Pulse 2.0, Pulse Pro 2.0 K183328Pulse Rx 2.0, Pulse Pro Rx 2.0 K221666Normatec Go K220217Normatec 3 K240122Normatec Elite

View all 8 devices →

Related Devices (Code: JOW)

K163055Reprocessed Kendall SCD Express Foot CuffCovidien K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. K161105Reprocessed Compression GarmentsCovidien K160431ActiveCare HomeMedical Compression Systems (Dbn) , Ltd. K161209Cirona 6400Devon Medical Products K150980Venous Assist SystemDaesung Maref Co., Ltd.

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.