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Balance Advantage Essential Spark System

Model 97P-0077 · BERTEC CORPORATION · DI 00850017250017

KHX — Platform, Force-Measuring · Class I · 21 CFR 890.1575

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — BERTEC CORPORATION

  • VAI 2024-02-12 Bertec Corp · 1 citations
  • VAI 2024-02-12 Bertec Corp · 1 citations