Medicom, TENS Electrodes

FDA 510(k) K965194 · Medicotest A/S

Substantially Equivalent

510(k) numberK965194

Submission

Device name
Medicom, TENS Electrodes
Applicant
Medicotest A/S
Washington, DC, US
Received
December 24, 1996
Decision date
March 6, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GXY – Electrode, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1320
Specialty
Neurology

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Questions and answers

When was Medicom, TENS Electrodes cleared by the FDA?

Medicom, TENS Electrodes (K965194) received a 510(k) decision of Substantially Equivalent on March 6, 1997, 72 days after the submission was received.

What is the product code of K965194?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.