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)

Compex Wireless USA

K-Number: K170903 · 2017-06-19

ApplicantDjo, LLC
Decision Date2017-06-19
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Compex Wireless USA is the device name listed in this FDA 510(k) record. The listed applicant is Djo, LLC. It received FDA 510(k) clearance on 2017-06-19 under 510(k) number K170903. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Compex Wireless USA?

Compex Wireless USA is a medical device that received FDA 510(k) clearance on 2017-06-19. The listed applicant is Djo, LLC. The 510(k) number is K170903.

When did Compex Wireless USA receive FDA 510(k) clearance?

Compex Wireless USA received FDA 510(k) clearance on 2017-06-19, under 510(k) number K170903.

Who is the listed applicant for Compex Wireless USA?

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

What is the FDA product code for Compex Wireless USA?

The FDA product code for Compex Wireless USA is NGX.

Other records listing Djo, LLC 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.

K201653Compex Sport Elite 3.0PMA P910066Stimulator, bone growth, non-invasiveK170918Compex Sport EliteK153704StriveK153696Chattanooga Revolution WirelessK153224VitalStim(R) Plus Electrotherapy System

View all 7 devices →

Related Devices (Code: NGX)

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.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

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.

↑