510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052309Substantially Equivalent

Digital Hand Dynamometer, Model Sh5003; Digital Pinch Gauge, Model Sh5006

Saehan Corporation, Flintville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052309 is the FDA 510(k) clearance record for DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006, a class II device, cleared for Saehan Corp. on under FDA product code LBB (Dynamometer, Ac-Powered). FDA records list one 510(k) clearance for Saehan Corp. As of , FDA records show no recalls naming K052309.

Clearance record

Decision date
Received
(34 days to decision)
Product code
LBB Dynamometer, Ac-Powered
Regulation
21 CFR 888.1240
Device class
Class II
Review panel
Orthopedic
Applicant
Saehan Corp. 340 Shady Grove Rd., Flintville TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBB

Trailing 12 months

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

FDA records show no clearances under product code LBB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LBB, 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