Class Class II

CoolTone (K253408)

K253408 2026-01-16 Traditional
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Description

CoolTone by Zimmer Medizinsysteme GmbH, an FDA 510(k) cleared physical medicine device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253408
Clearance Date2026-01-16
Clearance TypeTraditional
Product CodeNGX
Regulation Number890.5850

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