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)

VARAPULSE-2

K-Number: K952680 · 1995-12-04

ApplicantStaodyne, Inc.
Decision Date1995-12-04
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VARAPULSE-2 is the device name listed in this FDA 510(k) record. The listed applicant is Staodyne, Inc.. It received FDA 510(k) clearance on 1995-12-04 under 510(k) number K952680. 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 VARAPULSE-2?

VARAPULSE-2 is a medical device that received FDA 510(k) clearance on 1995-12-04. The listed applicant is Staodyne, Inc.. The 510(k) number is K952680.

When did VARAPULSE-2 receive FDA 510(k) clearance?

VARAPULSE-2 received FDA 510(k) clearance on 1995-12-04, under 510(k) number K952680.

Who is the listed applicant for VARAPULSE-2?

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

What is the FDA product code for VARAPULSE-2?

The FDA product code for VARAPULSE-2 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 Staodyne, 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.

K941923STERILE TREATMENT ELECTRODEK931925TPK CUTANEOUS ELECTRODEK926510STAODYN EMS+2K931424MAXIMA IK930865STAODYN MAXIMA IIIK925898MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS

View all 9 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.

↑