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)

ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800

K-Number: K023230 · 2003-05-05

ApplicantWestern Clinical Technology Systems, Inc.
Decision Date2003-05-05
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 is the device name listed in this FDA 510(k) record. The listed applicant is Western Clinical Technology Systems, Inc.. It received FDA 510(k) clearance on 2003-05-05 under 510(k) number K023230. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800?

ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 is a medical device that received FDA 510(k) clearance on 2003-05-05. The listed applicant is Western Clinical Technology Systems, Inc.. The 510(k) number is K023230.

When did ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 receive FDA 510(k) clearance?

ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 received FDA 510(k) clearance on 2003-05-05, under 510(k) number K023230.

Who is the listed applicant for ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800?

The FDA 510(k) record lists Western Clinical Technology Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800?

The FDA product code for ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 is IPF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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.

↑