The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Potable Air Massager Putifino, Model Am-7.
| Device ID | K071596 |
| 510k Number | K071596 |
| Device Name: | POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. 3F, 2-17-6 AKEBONO-CHO Tachikawa- Shi, JP 190-0012 |
| Contact | Koji Kubo |
| Correspondent | Koji Kubo NIHON SEIMITSU SOKKI CO., LTD. 3F, 2-17-6 AKEBONO-CHO Tachikawa- Shi, JP 190-0012 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-12 |
| Decision Date | 2008-02-15 |
| Summary: | summary |