510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973914Substantially Equivalent

Sense Technology Inc. Fras, Sense Technology Inc. Pulstar

Sense Technology, Inc., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973914 is the FDA 510(k) clearance record for SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR, cleared for Sense Technology, Inc. on under FDA product code LXM (Manipulator, Plunger-Like Joint). FDA records list 2 510(k) clearances for Sense Technology, Inc., from to . As of , FDA records show no recalls naming K973914.

Clearance record

Decision date
Received
(259 days to decision)
Product code
LXM Manipulator, Plunger-Like Joint
Device class
Unclassified
Review panel
Unknown
Applicant
Sense Technology, Inc. 3251 Old Frankstown Rd., Pittsburgh PA
510(k) summary
Statement
Third party review
No

Clearances, product code LXM

Trailing 12 months

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

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