VibraPEP
Spirometer, Therapeutic (incentive)
Medica Holdings, LLC
The following data is part of a premarket notification filed by Medica Holdings, Llc with the FDA for Vibrapep.
Pre-market Notification Details
| Device ID | K163091 |
| 510k Number | K163091 |
| Device Name: | VibraPEP |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | Medica Holdings, LLC 5200 Meadows Road Suite 150 Lake Osego, OR 97035 |
| Contact | George Reed |
| Correspondent | Paul Dryden ProMedic, LLC 24301 Woodsage Dr. Bonita Springs, FL 34134 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-04 |
| Decision Date | 2017-02-21 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812277032079 | K163091 | 000 |
| 00812277032031 | K163091 | 000 |
| 00810094573126 | K163091 | 000 |
| 00810094573119 | K163091 | 000 |
Trademark Results [VibraPEP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIBRAPEP 87078737 5192975 Live/Registered |
George Reed 2016-06-21 |
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