FDA 510(k) K202839, Overlapped Compression Therapy, by Jkh Health Co., Ltd.
FDA 510(k) K202839, Overlapped Compression Therapy, by Jkh Health Co., Ltd.
Device Classification Name: Sleeve, Limb, Compressible
510(k) Number: K202839
Device Name: Overlapped Compression Therapy
Applicant: Jkh Health Co., Ltd.
Regulation Number: 870.58
Classification Product Code: JOW
Date Received: 09/25/2020
Decision Date: 01/21/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular
Total number of pages: 962
Fully redacted pages: 834
Content pages: 128
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