IF8000— 510(k) K991241

Substantially Equivalent

Dan Med, Inc.

FDA 510(k) clearance K991241 for IF8000, Substantially Equivalent on 1999-11-02. Applicant: Dan Med, Inc.. Device class: 2.

Clearance details

Applicant: Dan Med, Inc.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1999-04-12
Decision date: 1999-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K991241

K-number listed on FDA's recall record

Z-1874-2014 — IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.Class II·Terminated·Zynex Medical, Inc.·20090125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991241.

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