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FDA 510(k)

PULSED GALVANIC STIMULATOR, 450-DYNAMAX

K-Number: K801053 · 1980-06-04

ApplicantU.S. Medical Corp.
Decision Date1980-06-04
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PULSED GALVANIC STIMULATOR, 450-DYNAMAX is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Medical Corp.. It received FDA 510(k) clearance on 1980-06-04 under 510(k) number K801053. 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 PULSED GALVANIC STIMULATOR, 450-DYNAMAX?

PULSED GALVANIC STIMULATOR, 450-DYNAMAX is a medical device that received FDA 510(k) clearance on 1980-06-04. The listed applicant is U.S. Medical Corp.. The 510(k) number is K801053.

When did PULSED GALVANIC STIMULATOR, 450-DYNAMAX receive FDA 510(k) clearance?

PULSED GALVANIC STIMULATOR, 450-DYNAMAX received FDA 510(k) clearance on 1980-06-04, under 510(k) number K801053.

Who is the listed applicant for PULSED GALVANIC STIMULATOR, 450-DYNAMAX?

The FDA 510(k) record lists U.S. Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULSED GALVANIC STIMULATOR, 450-DYNAMAX?

The FDA product code for PULSED GALVANIC STIMULATOR, 450-DYNAMAX is IPF.

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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

View on FDA Database →

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

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