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)

CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR

K-Number: K904360 · 1991-10-15

ApplicantMaximum Performance Technologies, Mpts, Inc.
Decision Date1991-10-15
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Maximum Performance Technologies, Mpts, Inc.. It received FDA 510(k) clearance on 1991-10-15 under 510(k) number K904360. 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 CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR?

CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR is a medical device that received FDA 510(k) clearance on 1991-10-15. The listed applicant is Maximum Performance Technologies, Mpts, Inc.. The 510(k) number is K904360.

When did CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR receive FDA 510(k) clearance?

CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR received FDA 510(k) clearance on 1991-10-15, under 510(k) number K904360.

Who is the listed applicant for CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR?

The FDA 510(k) record lists Maximum Performance Technologies, Mpts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR?

The FDA product code for CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR 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

Other records listing Maximum Performance Technologies, Mpts, Inc. 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.

K903148CHALLENGE 3000 NEUROLOGICAL BOOSTERK903149CHANLLENGE 1010 PATIENT KEY PROGRAM STATIONK902511CHALLENGE 7010 POWERED MUSCLE STIMULATORK902514CHALLENGE 5010 POWERED MUSCLE STIMULATORK902512CHALLENGE 8000 POWERED MUSCLE STIMULATORK902513CHALLENGE 6010 POWERED MUSCLE STIMULATOR

View all 11 devices →

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.

↑