510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953342Substantially Equivalent

Tmr48

Pride Health Care, Inc., West Wyoming PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953342 is the FDA 510(k) clearance record for TMR48, a class II device, cleared for Pride Health Care, Inc. on under FDA product code INO (Chair, Positioning, Electric). FDA records list 19 510(k) clearances for Pride Health Care, Inc., from to . As of , FDA records show one recall naming K953342.

Clearance record

Decision date
Received
(59 days to decision)
Product code
INO Chair, Positioning, Electric
Regulation
21 CFR 890.3110
Device class
Class II
Review panel
Physical Medicine
Applicant
Pride Health Care, Inc. 259 W. 6th St., West Wyoming PA
510(k) summary
Statement
Third party review
No

Clearances, product code INO

Trailing 12 months

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

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