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FDA 510(k)

UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500

K-Number: K905107 · 1991-08-19

ApplicantUniversal Technology Systems, Inc.
Decision Date1991-08-19
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500 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 1991-08-19 under 510(k) number K905107. 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 UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500?

UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500 is a medical device that received FDA 510(k) clearance on 1991-08-19. The listed applicant is Universal Technology Systems, Inc.. The 510(k) number is K905107.

When did UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500 receive FDA 510(k) clearance?

UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500 received FDA 510(k) clearance on 1991-08-19, under 510(k) number K905107.

Who is the listed applicant for UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500?

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 UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500?

The FDA product code for UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500 is IPF.

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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.

K980346ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)K895760ELECTRICAL 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.

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Official Source

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