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)

VERSA STIM 380, MUSCLE STIMULATOR

K-Number: K852077 · 1985-08-21

ApplicantElectro-Med Health Industries, Inc.
Decision Date1985-08-21
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

VERSA STIM 380, MUSCLE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Med Health Industries, Inc.. It received FDA 510(k) clearance on 1985-08-21 under 510(k) number K852077. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the VERSA STIM 380, MUSCLE STIMULATOR?

VERSA STIM 380, MUSCLE STIMULATOR is a medical device that received FDA 510(k) clearance on 1985-08-21. The listed applicant is Electro-Med Health Industries, Inc.. The 510(k) number is K852077.

When did VERSA STIM 380, MUSCLE STIMULATOR receive FDA 510(k) clearance?

VERSA STIM 380, MUSCLE STIMULATOR received FDA 510(k) clearance on 1985-08-21, under 510(k) number K852077.

Who is the listed applicant for VERSA STIM 380, MUSCLE STIMULATOR?

The FDA 510(k) record lists Electro-Med Health Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERSA STIM 380, MUSCLE STIMULATOR?

The FDA product code for VERSA STIM 380, MUSCLE 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 Electro-Med Health Industries, 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.

K832371EGS MODEL 300K832803STEAM PAK MOIST HEATK832804SESAM TABLEK832370EGS MODEL 100-2K802107EGS #300 BATTERY OPER. PORTA. MUSCLE STI

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.

↑