TENS Lead

FDA 510(k) K873608 · Desco Industries, Inc.

Substantially Equivalent

510(k) numberK873608

Submission

Device name
TENS Lead
Applicant
Desco Industries, Inc.
Walnut, CA, US
Received
September 8, 1987
Decision date
September 30, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GZI – Stimulator, Neuromuscular, External Functional
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5810
Specialty
Neurology

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More from Guangzhou Longest Science & Technology Co., Ltd.

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Questions and answers

When was TENS Lead cleared by the FDA?

TENS Lead (K873608) received a 510(k) decision of Substantially Equivalent on September 30, 1987, 22 days after the submission was received.

What is the product code of K873608?

The FDA product code is GZI – Stimulator, Neuromuscular, External Functional, a Class II (moderate risk) device regulated under 21 CFR 882.5810.