510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K925977Substantially Equivalent

Paramed Flexion-Extension Machine

Paramed Services, Inc., Knoxville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925977 is the FDA 510(k) clearance record for PARAMED FLEXION-EXTENSION MACHINE, a class I device, cleared for Paramed Services, Inc. on under FDA product code BXB (Exerciser, Powered). FDA records list one 510(k) clearance for Paramed Services, Inc. As of , FDA records show no recalls naming K925977.

Clearance record

Decision date
Received
(126 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Paramed Services, Inc. P.O. Box 1986, Knoxville TN
510(k) summary
Statement
Third party review
No

Clearances, product code BXB

Trailing 12 months

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

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