Reusable TENS Paravertebral Pad #641 Back Electrod
FDA 510(k) K901575 · Pioneering Technologies, Inc.
510(k) numberK901575
Submission
- Device name
- Reusable TENS Paravertebral Pad #641 Back Electrod
- Applicant
- Pioneering Technologies, Inc.
Wabasha, MN, US - Received
- April 3, 1990
- Decision date
- May 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Reusable TENS Paravertebral Pad #641 Back Electrod cleared by the FDA?
Reusable TENS Paravertebral Pad #641 Back Electrod (K901575) received a 510(k) decision of Substantially Equivalent on May 2, 1990, 29 days after the submission was received.
What is the product code of K901575?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.