The following data is part of a premarket notification filed by Cymedica Orthopedics, Inc. with the FDA for Qb1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator.
| Device ID | K150413 |
| 510k Number | K150413 |
| Device Name: | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator |
| Classification | Stimulator, Muscle, Powered |
| Applicant | CyMedica Orthopedics, Inc. 19120 N. Pima Rd. Suite 135 Scottsdale, AZ 85255 |
| Contact | Kereshmeh Shahriari |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854816006806 | K150413 | 000 |
| 00854691008209 | K150413 | 000 |
| 00854691008193 | K150413 | 000 |
| 00854691008186 | K150413 | 000 |
| 00854691008179 | K150413 | 000 |
| 00854691008162 | K150413 | 000 |
| 00854691008711 | K150413 | 000 |
| 00854691008704 | K150413 | 000 |
| 00854691008698 | K150413 | 000 |
| 00854691008216 | K150413 | 000 |
| 00854691008223 | K150413 | 000 |
| 00854691008230 | K150413 | 000 |
| 00854691008315 | K150413 | 000 |
| 00854691008308 | K150413 | 000 |
| 00854691008292 | K150413 | 000 |
| 00854691008285 | K150413 | 000 |
| 00854691008278 | K150413 | 000 |
| 00854691008261 | K150413 | 000 |
| 00854691008254 | K150413 | 000 |
| 00854691008247 | K150413 | 000 |
| 00854691008681 | K150413 | 000 |