Tru-Pulse Pads
FDA 510(k) K800117 · Ipco Corp.
510(k) numberK800117
Submission
- Device name
- Tru-Pulse Pads
- Applicant
- Ipco Corp.
Mchenry, IL, US - Received
- January 18, 1980
- Decision date
- February 11, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Tru-Pulse Pads cleared by the FDA?
Tru-Pulse Pads (K800117) received a 510(k) decision of Substantially Equivalent on February 11, 1980, 24 days after the submission was received.
What is the product code of K800117?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.