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)

MARK V HIGH VOLTAGE GALVANIC STIMULATORR

K-Number: K832546 · 1983-10-14

ApplicantOrthion Corp.
Decision Date1983-10-14
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MARK V HIGH VOLTAGE GALVANIC STIMULATORR is the device name listed in this FDA 510(k) record. The listed applicant is Orthion Corp.. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832546. 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 MARK V HIGH VOLTAGE GALVANIC STIMULATORR?

MARK V HIGH VOLTAGE GALVANIC STIMULATORR is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Orthion Corp.. The 510(k) number is K832546.

When did MARK V HIGH VOLTAGE GALVANIC STIMULATORR receive FDA 510(k) clearance?

MARK V HIGH VOLTAGE GALVANIC STIMULATORR received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832546.

Who is the listed applicant for MARK V HIGH VOLTAGE GALVANIC STIMULATORR?

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

What is the FDA product code for MARK V HIGH VOLTAGE GALVANIC STIMULATORR?

The FDA product code for MARK V HIGH VOLTAGE GALVANIC STIMULATORR 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 Orthion Corp. 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.

K823152OB HELP ARMK823154SHOWER STOOL W/HANDLESK823151OB TRIPP TRANSPORT CHAIRK823149OB TILT TABLEK823105RESI-WALKERK823155LAVATORY SEAT HEIGHTENER

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.

↑