Cryon-X Cold Compression— 510(k) K253150

Substantially Equivalent

Jkh Health Co., Ltd.

FDA 510(k) clearance K253150 for Cryon-X Cold Compression, Substantially Equivalent on 2025-10-24. Applicant: Jkh Health Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jkh Health Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2025-09-25
Decision date: 2025-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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