Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is NormaTec Industries, LP. It received FDA 510(k) clearance on 2018-12-21 under 510(k) 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. The listed applicant is NormaTec Industries, LP. The 510(k) number is K183328.

When did Pulse Rx 2.0, Pulse Pro Rx 2.0 receive FDA 510(k) clearance?

Pulse Rx 2.0, Pulse Pro Rx 2.0 received FDA 510(k) clearance on 2018-12-21, under 510(k) number K183328.

Who is the listed applicant for Pulse Rx 2.0, Pulse Pro Rx 2.0?

The FDA 510(k) record lists NormaTec Industries, LP as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing NormaTec Industries, LP as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251905Normatec Elite HipK240122Normatec EliteK221666Normatec GoK220217Normatec 3K183169Pulse 2.0, Pulse Pro 2.0K161346NormaTec PCD-T and PCD-B

View all 8 devices →

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments 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.

↑