510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K214037Substantially Equivalent

Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac

ERGO FLEX Technologies LLC, Conroe TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K214037 is the FDA 510(k) clearance record for Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac, a class II device, cleared for Ergo-Flex Technologies, LLC on under FDA product code ITH (Equipment, Traction, Powered). FDA records list one 510(k) clearance for Ergo-Flex Technologies, LLC. As of , FDA records show no recalls naming K214037.

Clearance record

Decision date
Received
(791 days to decision)
Product code
ITH Equipment, Traction, Powered
Regulation
21 CFR 890.5900
Device class
Class II
Review panel
Physical Medicine
Applicant
Ergo-Flex Technologies, LLC 13622 Poplar Cir., Conroe TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ITH

Trailing 12 months

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

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