ACCU-PULSE TENS UNIT— 510(k) K010203

Substantially Equivalent

Sadler Electronics

FDA 510(k) clearance K010203 for ACCU-PULSE TENS UNIT, Substantially Equivalent on 2001-08-28. Applicant: Sadler Electronics. Device class: 2.

Clearance details

Applicant: Sadler Electronics
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2001-01-22
Decision date: 2001-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edgemead, ZA

Download summary PDF View on FDA.gov ↗

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