510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950377Substantially Equivalent

Parker Model Pe

Parker Treadmill Co., Inc., Auburn AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950377 is the FDA 510(k) clearance record for PARKER MODEL PE, a class I device, cleared for Parker Treadmill Co., Inc. on under FDA product code IOL (Treadmill, Powered). FDA records list 2 510(k) clearances for Parker Treadmill Co., Inc. As of , FDA records show no recalls naming K950377.

Clearance record

Decision date
Received
(218 days to decision)
Product code
IOL Treadmill, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Parker Treadmill Co., Inc. 368 Industry Dr., Auburn AL
510(k) summary
Statement
Third party review
No

Clearances, product code IOL

Trailing 12 months

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

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