The following data is part of a premarket notification filed by Suzhou Kd Medical Appliance Co., Ltd. with the FDA for Power Wheelchair.
| Device ID | K113463 |
| 510k Number | K113463 |
| Device Name: | POWER WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | SUZHOU KD MEDICAL APPLIANCE CO., LTD. 16F-2(16A), NO. 462 SEC. 2 CHONGDE DR., BEITUN DIST. Taichung, TW 406 |
| Contact | Junnata Chang |
| Correspondent | Junnata Chang SUZHOU KD MEDICAL APPLIANCE CO., LTD. 16F-2(16A), NO. 462 SEC. 2 CHONGDE DR., BEITUN DIST. Taichung, TW 406 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-22 |
| Decision Date | 2012-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970575220179 | K113463 | 000 |
| 06970575220025 | K113463 | 000 |
| 06970575220032 | K113463 | 000 |
| 06970575220049 | K113463 | 000 |
| 06970575220056 | K113463 | 000 |
| 06970575220063 | K113463 | 000 |
| 06970575220070 | K113463 | 000 |
| 06970575220131 | K113463 | 000 |
| 06970575220186 | K113463 | 000 |
| 06970575220087 | K113463 | 000 |
| 06970575220094 | K113463 | 000 |
| 06970575220100 | K113463 | 000 |
| 06970575220117 | K113463 | 000 |
| 06970575220124 | K113463 | 000 |
| 06970575220148 | K113463 | 000 |
| 06970575220155 | K113463 | 000 |
| 06970575220162 | K113463 | 000 |
| 06970575220018 | K113463 | 000 |