Neurotherm, Inc.
Wilmington, MA, US
Neurotherm, Inc. appears in FDA device records in Wilmington, MA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 3
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1361-2016 | Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX | NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in the United States for use. | Class II | Terminated | |
| Z-1247-2016 | Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads. | Straight needle labeled as a curved needle | Class II | Terminated | |
| Z-0838-2009 | NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue. | Distal tip may detach from the probe | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain