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FDA 510(k)

ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)

K-Number: K980346 · 1998-04-28

ApplicantUniversal Technology Systems, Inc.
Decision Date1998-04-28
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) is the device name listed in this FDA 510(k) record. The listed applicant is Universal Technology Systems, Inc.. It received FDA 510(k) clearance on 1998-04-28 under 510(k) number K980346. 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 ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)?

ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) is a medical device that received FDA 510(k) clearance on 1998-04-28. The listed applicant is Universal Technology Systems, Inc.. The 510(k) number is K980346.

When did ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) receive FDA 510(k) clearance?

ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) received FDA 510(k) clearance on 1998-04-28, under 510(k) number K980346.

Who is the listed applicant for ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)?

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

What is the FDA product code for ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)?

The FDA product code for ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) 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 Universal Technology Systems, 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.

K905107UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500K895760ELECTRICAL MUSCLE STIMULATOR--PGS 2000 TENS DEVICE

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

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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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