SELECT TENS, MODEL 4600S— 510(k) K061650

Substantially Equivalent

Empi

FDA 510(k) clearance K061650 for SELECT TENS, MODEL 4600S, Substantially Equivalent on 2007-01-22. Applicant: Empi. Device class: 2.

Clearance details

Applicant: Empi
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2006-06-13
Decision date: 2007-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.