The following data is part of a De Novo classification by Sensory Medical, Inc with the FDA for Symphony Device.
| DeNovo ID | DEN110011 |
| Device Name: | SYMPHONY DEVICE |
| Classification | Vibratory Counter-stimulation |
| Applicant | SENSORY MEDICAL, INC 1235 Puerta Del Sol #500 San Clemente, CA 92673 |
| Contact | Fred Burbank |
| Product Code | OVP |
| CFR Regulation Number | 882.5895 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K102873 |
| Review Advisory Board | Neurology |
| Classification Advisory | Physical Medicine |
| Type | Post-NSE |
| Date Received | 2011-07-13 |
| Decision Date | 2013-12-18 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852335007090 | DEN110011 | 000 |
| 00852335007083 | DEN110011 | 000 |
| 00852335007076 | DEN110011 | 000 |
| 00852335007069 | DEN110011 | 000 |
| 00852335007052 | DEN110011 | 000 |
| 00852335007038 | DEN110011 | 000 |
| 00852335007021 | DEN110011 | 000 |