EASY TOUCH— 510(k) K102178

Substantially Equivalent

Mhc Medical Products

FDA 510(k) clearance K102178 for EASY TOUCH, Substantially Equivalent on 2010-09-02. Applicant: Mhc Medical Products.

Clearance details

Applicant: Mhc Medical Products
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2010-08-03
Decision date: 2010-09-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.