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)

MODEL #810 STEALTH-STIM ADULT STIMULATION PADS

K-Number: K913226 · 1991-09-04

ApplicantCardiotronics, Inc.
Decision Date1991-09-04
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL #810 STEALTH-STIM ADULT STIMULATION PADS is the device name listed in this FDA 510(k) record. The listed applicant is Cardiotronics, Inc.. It received FDA 510(k) clearance on 1991-09-04 under 510(k) number K913226. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL #810 STEALTH-STIM ADULT STIMULATION PADS?

MODEL #810 STEALTH-STIM ADULT STIMULATION PADS is a medical device that received FDA 510(k) clearance on 1991-09-04. The listed applicant is Cardiotronics, Inc.. The 510(k) number is K913226.

When did MODEL #810 STEALTH-STIM ADULT STIMULATION PADS receive FDA 510(k) clearance?

MODEL #810 STEALTH-STIM ADULT STIMULATION PADS received FDA 510(k) clearance on 1991-09-04, under 510(k) number K913226.

Who is the listed applicant for MODEL #810 STEALTH-STIM ADULT STIMULATION PADS?

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

What is the FDA product code for MODEL #810 STEALTH-STIM ADULT STIMULATION PADS?

The FDA product code for MODEL #810 STEALTH-STIM ADULT STIMULATION PADS is DRX.

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 Cardiotronics, 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.

K932903EKG VESTK922064MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODEK923297MODEL #340 STEALTH-TRODE+LSK922227MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILEK922172MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)K922173MODEL # 830 ST ADULT STIMULATION PADS (STERILE)

View all 27 devices →

Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing 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.

↑