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Curonix LLC

Pompano Beach, FL, US

CURONIX LLC appears in FDA device records in Pompano Beach, FL. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
6
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Curonix LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Stimwave Technologies, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Curonix LLC between 2019 and 2024. The busiest year on record is 2019, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Curonix LLC, by decision year
YearClearances
20191
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K233162Freedom Peripheral Nerve Stimulator (PNS) SystemGZFSubstantially Equivalent
K191466SandShark Injectable Anchor (SIA) SystemGZBSubstantially Equivalent

Registered establishments

FDA registered establishments for Curonix LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30106761383010676138CURONIX LLC1310 Park Central Boulevard S, Pompano Beach, FL 33064 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2933-2020StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.The product contains a non-functional component not referenced in product labeling.Class IIOpen, Classified
Z-2932-2020StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.The product contains a non-functional component not referenced in product labeling.Class IIOpen, Classified
Z-2931-2020StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.The product contains a non-functional component not referenced in product labeling.Class IIOpen, Classified
Z-2930-2020StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.The product contains a non-functional component not referenced in product labeling.Class IIOpen, Classified
Z-2929-2020StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.The product contains a non-functional component not referenced in product labeling.Class IIOpen, Classified
Z-2928-2020StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.The product contains a non-functional component not referenced in product labeling.Class IIOpen, Classified

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