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ERGO FLEX Technologies LLC

Conroe, TX, US

ERGO FLEX Technologies LLC appears in FDA device records in Conroe, TX. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for ERGO FLEX Technologies LLC in 2024.

Clearances by year, as a table
510(k) clearance decisions for ERGO FLEX Technologies LLC, by decision year
YearClearances
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracITHSubstantially Equivalent

Registered establishments

FDA registered establishments for ERGO FLEX Technologies LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30096849233009684923ERGO FLEX Technologies LLC13622 Poplar Circle, Conroe, TX 77304 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain