510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031375Substantially Equivalent

Besmed Various Models of Powered Muscle Stimulator, Be-560/Be-580

Besmed Health Business Corporation, Hsin Chu City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031375 is the FDA 510(k) clearance record for BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580, a class II device, cleared for Besmed Health Business Corp on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 11 510(k) clearances for Besmed Health Business Corp, from to . As of , FDA records show no recalls naming K031375.

Clearance record

Decision date
Received
(204 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Besmed Health Business Corp 58 Fu-Chiun St., Hsin Chu City, TW
510(k) summary
Statement
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260