K223541
- 510(k) number
- K223541
- Device name
- Cold/Hot Compression
- Applicant
- Jkh Health Co., Ltd. CN
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2023-10-27
- Date received
- 2022-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K223541.pdf
Official FDA record: K223541
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.