The following data is part of a premarket notification filed by Global Fabtech Wheel Chair (shanghai) Co., Ltd. with the FDA for Zip'r Pc.
| Device ID | K072224 |
| 510k Number | K072224 |
| Device Name: | ZIP'R PC |
| Classification | Wheelchair, Powered |
| Applicant | GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD. 14F-2, NO.1 LANE 25 ZHUANGJING ROAD Banqiao, Taipei County, TW 220 |
| Contact | Junnata Chang |
| Correspondent | Junnata Chang GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD. 14F-2, NO.1 LANE 25 ZHUANGJING ROAD Banqiao, Taipei County, TW 220 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-10 |
| Decision Date | 2007-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972356130097 | K072224 | 000 |