The following data is part of a premarket notification filed by Global Fabtech Wheelchair (shanghai) Co., Ltd. with the FDA for Zip'r3/ Zip'r3 Xtra Scooter.
| Device ID | K102358 |
| 510k Number | K102358 |
| Device Name: | ZIP'R3/ ZIP'R3 XTRA SCOOTER |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD. 16F-2 (16A), NO.462, SEC.2, CHONGDE RD, BEITUN DIST. Taichung, Taiwan (china), TW 406 |
| Contact | Junnata Chang |
| Correspondent | Junnata Chang GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD. 16F-2 (16A), NO.462, SEC.2, CHONGDE RD, BEITUN DIST. Taichung, Taiwan (china), 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 | 2010-08-19 |
| Decision Date | 2010-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972356130066 | K102358 | 000 |
| 06972356130059 | K102358 | 000 |
| 06972356130028 | K102358 | 000 |
| 06972356130011 | K102358 | 000 |