510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971407Substantially Equivalent

Jtech Commander and Algometer

J-Tech Medical, Inc., Heber City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971407 is the FDA 510(k) clearance record for JTECH COMMANDER AND ALGOMETER, a class I device, cleared for J-Tech Medical, Inc. on under FDA product code HRW (Dynamometer, Nonpowered). FDA records list 2 510(k) clearances for J-Tech Medical, Inc., from to . As of , FDA records show no recalls naming K971407.

Clearance record

Decision date
Received
(369 days to decision)
Product code
HRW Dynamometer, Nonpowered
Regulation
21 CFR 888.1250
Device class
Class I
Review panel
Orthopedic
Applicant
J-Tech Medical, Inc. 357 W. 910 S., Heber City UT
510(k) summary
Statement
Third party review
No

Clearances, product code HRW

Trailing 12 months

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

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