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)

AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION

K-Number: K972997 · 1997-11-10

ApplicantDan Med, Inc.
Decision Date1997-11-10
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION is the device name listed in this FDA 510(k) record. The listed applicant is Dan Med, Inc.. It received FDA 510(k) clearance on 1997-11-10 under 510(k) number K972997. 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 AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION?

AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION is a medical device that received FDA 510(k) clearance on 1997-11-10. The listed applicant is Dan Med, Inc.. The 510(k) number is K972997.

When did AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION receive FDA 510(k) clearance?

AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION received FDA 510(k) clearance on 1997-11-10, under 510(k) number K972997.

Who is the listed applicant for AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION?

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

What is the FDA product code for AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION?

The FDA product code for AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION 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 Dan Med, 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.

K013210TRUWAVEK012885NEUROMOVE NM900K010745EMS 3000K991241IF8000K964738ELPHA 2000 CONTI

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.

↑