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FDA 510(k)

MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000

K-Number: K874232 · 1989-03-10

ApplicantHealth Systems Intl., Inc.
Decision Date1989-03-10
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000 is the device name listed in this FDA 510(k) record. The listed applicant is Health Systems Intl., Inc.. It received FDA 510(k) clearance on 1989-03-10 under 510(k) number K874232. 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 MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000?

MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000 is a medical device that received FDA 510(k) clearance on 1989-03-10. The listed applicant is Health Systems Intl., Inc.. The 510(k) number is K874232.

When did MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000 receive FDA 510(k) clearance?

MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000 received FDA 510(k) clearance on 1989-03-10, under 510(k) number K874232.

Who is the listed applicant for MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000?

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

What is the FDA product code for MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000?

The FDA product code for MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000 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 Health Systems Intl., 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.

K881492MTI WOLFF SYSTEM, TANNING BEDK881353MTI WOLFF SYSTEMK862372ULTRATAN TANNING SYSTEM

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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