TENS PRO 900— 510(k) K915663

Substantially Equivalent

Acuhealth (Usa) Pty. , Ltd.

FDA 510(k) clearance K915663 for TENS PRO 900, Substantially Equivalent on 1993-04-15. Applicant: Acuhealth (Usa) Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: Acuhealth (Usa) Pty. , Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1991-12-18
Decision date: 1993-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eugene, OR, 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.