NTRAINER SYSTEM
Device, Biofeedback
KCBIOMEDIX, INC.
The following data is part of a premarket notification filed by Kcbiomedix, Inc. with the FDA for Ntrainer System.
Pre-market Notification Details
| Device ID | K071866 |
| 510k Number | K071866 |
| Device Name: | NTRAINER SYSTEM |
| Classification | Device, Biofeedback |
| Applicant | KCBIOMEDIX, INC. 4200 SW SAPELO DR. Lees Summit, MO 64082 |
| Contact | James E Stanley |
| Correspondent | James E Stanley KCBIOMEDIX, INC. 4200 SW SAPELO DR. Lees Summit, MO 64082 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-06 |
| Decision Date | 2008-02-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B184A100020 | K071866 | 000 |
| 00860009695214 | K071866 | 000 |
| 10860009695228 | K071866 | 000 |
| 10860009695235 | K071866 | 000 |
| 10860009695242 | K071866 | 000 |
| 10860009695259 | K071866 | 000 |
| 10860009695266 | K071866 | 000 |
| 10885380195587 | K071866 | 000 |
| 10885380195556 | K071866 | 000 |
| 00196852124213 | K071866 | 000 |
| 00196852125432 | K071866 | 000 |
| 10196852173638 | K071866 | 000 |
| 10196852668189 | K071866 | 000 |
| 00860000688604 | K071866 | 000 |
| 00860000688611 | K071866 | 000 |
| B184A000020 | K071866 | 000 |
| 00860009695207 | K071866 | 000 |
Trademark Results [NTRAINER SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NTRAINER SYSTEM 77376308 3617036 Live/Registered |
INNARA HEALTH, INC. 2008-01-21 |
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