510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912057Substantially Equivalent

4000 Pt Exercise System

Tri-Tech, Inc., Fort Woth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912057 is the FDA 510(k) clearance record for 4000 PT EXERCISE SYSTEM, a class II device, cleared for Tri-Tech, Inc. on under FDA product code ISD (Exerciser, Measuring). FDA records list 11 510(k) clearances for Tri-Tech, Inc., from to . As of , FDA records show no recalls naming K912057.

Clearance record

Decision date
Received
(168 days to decision)
Product code
ISD Exerciser, Measuring
Regulation
21 CFR 890.5360
Device class
Class II
Review panel
Physical Medicine
Applicant
Tri-Tech, Inc. C/O Richard Hamer Assoc.Inc., Fort Woth TX
510(k) summary
Statement
Third party review
No

Clearances, product code ISD

Trailing 12 months

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

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