The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Iprophy Mobile.
| Device ID | K131578 |
| 510k Number | K131578 |
| Device Name: | IPROPHY MOBILE |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-31 |
| Decision Date | 2013-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7022659960 | K131578 | 000 |
| D7022659930 | K131578 | 000 |
| D7022659910 | K131578 | 000 |
| D7022659920 | K131578 | 000 |
| D7020659910 | K131578 | 000 |
| D7020659900 | K131578 | 000 |