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FDA 510(k)

TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR

K-Number: K042350 · 2004-11-03

ApplicantCadwell Laboratories, Inc.
Decision Date2004-11-03
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 2004-11-03 under 510(k) number K042350. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR?

TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR is a medical device that received FDA 510(k) clearance on 2004-11-03. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K042350.

When did TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR receive FDA 510(k) clearance?

TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR received FDA 510(k) clearance on 2004-11-03, under 510(k) number K042350.

Who is the listed applicant for TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR?

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

What is the FDA product code for TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR?

The FDA product code for TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR is GWF.

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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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