The following data is part of a premarket notification filed by Prestige Sporting Goods Co. Ltd. with the FDA for Prestige-mobie.
| Device ID | K122749 |
| 510k Number | K122749 |
| Device Name: | PRESTIGE-MOBIE |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | PRESTIGE SPORTING GOODS CO. LTD. 16F-2(16A), NO. 462, SEC. 2 CHONGDE RD., BEITUN DIST. Taichung, TW 406 |
| Contact | Junnata Chang |
| Correspondent | Junnata Chang PRESTIGE SPORTING GOODS CO. LTD. 16F-2(16A), NO. 462, SEC. 2 CHONGDE RD., BEITUN DIST. Taichung, TW 406 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-07 |
| Decision Date | 2012-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822383570471 | K122749 | 000 |