TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.— 510(k) K992310

Name: FDA 510(k) clearance K992310
Creator: U.S. Food and Drug Administration
Published: 1999-11-02

Substantially Equivalent

Rupiani Medical

FDA 510(k) clearance K992310 for TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4., Substantially Equivalent on 1999-11-02. Applicant: Rupiani Medical. Device class: 1.

Clearance details

Applicant: Rupiani Medical
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 1999-07-09
Decision date: 1999-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vaulx En Velin, FR

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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