510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130311Substantially Equivalent

Transtek Body Fat Analyzer

Guangdong Transtek Medical Electronics Co.,Ltd, Chengdu, Sichuan, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130311 is the FDA 510(k) clearance record for TRANSTEK BODY FAT ANALYZER, a class II device, cleared for Guangdong Transtek Medical Electronics Co., Ltd. on under FDA product code MNW (Analyzer, Body Composition). FDA records list 17 510(k) clearances for Guangdong Transtek Medical Electronics Co., Ltd., from to . As of , FDA records show no recalls naming K130311.

Clearance record

Decision date
Received
(111 days to decision)
Product code
MNW Analyzer, Body Composition
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Guangdong Transtek Medical Electronics Co., Ltd. #1 Fanghua St., Hi-Tech District, Chengdu, Sichuan, CN
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