Spect.E.N.S. Repostion.-E Foam Pin Type TENS Elect
FDA 510(k) K902719 · Labeltape Meditect, Inc.
510(k) numberK902719
Submission
- Device name
- Spect.E.N.S. Repostion.-E Foam Pin Type TENS Elect
- Applicant
- Labeltape Meditect, Inc.
Grand Rapids, MI, US - Received
- June 20, 1990
- Decision date
- July 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Spect.E.N.S. Repostion.-E Foam Pin Type TENS Elect cleared by the FDA?
Spect.E.N.S. Repostion.-E Foam Pin Type TENS Elect (K902719) received a 510(k) decision of Substantially Equivalent on July 19, 1990, 29 days after the submission was received.
What is the product code of K902719?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.