The following data is part of a premarket notification filed by Neuromechanical Innovations, Llc with the FDA for Impulse Iq Adjusting Instrument.
| Device ID | K080261 |
| 510k Number | K080261 |
| Device Name: | IMPULSE IQ ADJUSTING INSTRUMENT |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | NEUROMECHANICAL INNOVATIONS, LLC 11011 SOUTH 48TH ST., STE. 220 Phoenix, AZ 85044 |
| Contact | Christopher J Colloca |
| Correspondent | Christopher J Colloca NEUROMECHANICAL INNOVATIONS, LLC 11011 SOUTH 48TH ST., STE. 220 Phoenix, AZ 85044 |
| Product Code | LXM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-01 |
| Decision Date | 2008-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011416418 | K080261 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IMPULSE IQ ADJUSTING INSTRUMENT 77563701 3665972 Live/Registered |
Neuromechanical Innovations, LLC 2008-09-05 |