510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910149Substantially Equivalent

Romflex Rehab Equip Lateral Flexion Unit

Dyna Flex, Intl., Clinton TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910149 is the FDA 510(k) clearance record for ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT, a class I device, cleared for Dyna Flex, Intl. on under FDA product code BXB (Exerciser, Powered). FDA records list 4 510(k) clearances for Dyna Flex, Intl., from to . As of , FDA records show no recalls naming K910149.

Clearance record

Decision date
Received
(4 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Dyna Flex, Intl. 151 E. Broad St., Clinton TN
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