510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053556Substantially Equivalent

Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5

Jawon Medical Co., Ltd., Seoul, Korea, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053556 is the FDA 510(k) clearance record for BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5, a class II device, cleared for Jawon Medical Co., Ltd. on under FDA product code MNW (Analyzer, Body Composition). FDA records list 13 510(k) clearances for Jawon Medical Co., Ltd., from to . As of , FDA records show no recalls naming K053556.

Clearance record

Decision date
Received
(254 days to decision)
Product code
MNW Analyzer, Body Composition
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Jawon Medical Co., Ltd. Rm. 624, Life Officetel, 61-3, Seoul, Korea, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNW

Trailing 12 months

FDA records hold no clearances under product code MNW in the trailing twelve months.

FDA records show no clearances under product code MNW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MNW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260