Comfort Stim

FDA 510(k) K001117 · R & D Medical Products, Inc.

Substantially Equivalent

510(k) numberK001117

Submission

Device name
Comfort Stim
Applicant
R & D Medical Products, Inc.
Lake Forest, CA, US
Received
April 6, 2000
Decision date
July 5, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 Comfort Stim cleared by the FDA?

Comfort Stim (K001117) received a 510(k) decision of Substantially Equivalent on July 5, 2000, 90 days after the submission was received.

What is the product code of K001117?

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