The following data is part of a premarket notification filed by Intco Metal Products (zhenjiang) Co., Ltd. with the FDA for Yk9000 Series Manual Wheelchair.
| Device ID | K052468 |
| 510k Number | K052468 |
| Device Name: | YK9000 SERIES MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | INTCO METAL PRODUCTS (ZHENJIANG) CO., LTD. 12390 EAST END AVENUE Chino, CA 91710 |
| Contact | John Zhao |
| Correspondent | John Zhao INTCO METAL PRODUCTS (ZHENJIANG) CO., LTD. 12390 EAST END AVENUE Chino, CA 91710 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-08 |
| Decision Date | 2005-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447114680 | K052468 | 000 |
| M368EJ78411 | K052468 | 000 |
| M368EJ78511 | K052468 | 000 |
| M368EJ78611 | K052468 | 000 |
| M368EJ78711 | K052468 | 000 |
| M368EJ78811 | K052468 | 000 |
| M368EJ79011 | K052468 | 000 |
| M368EJ79111 | K052468 | 000 |
| M368EJ79211 | K052468 | 000 |
| M368EJ79311 | K052468 | 000 |
| M368EJ79511 | K052468 | 000 |
| M368EJ79611 | K052468 | 000 |
| 10885632079870 | K052468 | 000 |
| 10885632079894 | K052468 | 000 |
| 10885632079900 | K052468 | 000 |
| 10885632079979 | K052468 | 000 |
| M368EJ78311 | K052468 | 000 |
| M368EJ78211 | K052468 | 000 |
| 00841447114697 | K052468 | 000 |
| 00841447114727 | K052468 | 000 |
| 00841447114734 | K052468 | 000 |
| 00841447114741 | K052468 | 000 |
| 00841447114758 | K052468 | 000 |
| 00841447114765 | K052468 | 000 |
| 00841447114772 | K052468 | 000 |
| 00841447114789 | K052468 | 000 |
| 00841447114796 | K052468 | 000 |
| 00841447114802 | K052468 | 000 |
| 00841447114819 | K052468 | 000 |
| 20665973031709 | K052468 | 000 |
| 30665973031393 | K052468 | 000 |
| 30665973031409 | K052468 | 000 |
| M368EJ78111 | K052468 | 000 |
| 10885632080005 | K052468 | 000 |
| 10885632080012 | K052468 | 000 |
| M3683H0203501 | K052468 | 000 |
| M3683H0211001 | K052468 | 000 |
| M3683H0211101 | K052468 | 000 |
| M3683H0211201 | K052468 | 000 |
| M3683H0211301 | K052468 | 000 |
| M3683H0212201 | K052468 | 000 |
| M3683H0212301 | K052468 | 000 |
| M3683H0213201 | K052468 | 000 |
| M3683H0213301 | K052468 | 000 |
| M368EJ87011 | K052468 | 000 |
| M368EJ87111 | K052468 | 000 |
| 10612479215457 | K052468 | 000 |
| 10612479215471 | K052468 | 000 |
| 00822383140438 | K052468 | 000 |
| 00822383140452 | K052468 | 000 |
| M3683H0203401 | K052468 | 000 |
| M3683H0203301 | K052468 | 000 |
| 10885632080029 | K052468 | 000 |
| 10885632087844 | K052468 | 000 |
| 10885632087851 | K052468 | 000 |
| 10885632087868 | K052468 | 000 |
| 10885632127717 | K052468 | 000 |
| 20885632079990 | K052468 | 000 |
| 20885632087872 | K052468 | 000 |
| M3683H0201001 | K052468 | 000 |
| M3683H0201101 | K052468 | 000 |
| M3683H0201201 | K052468 | 000 |
| M3683H0201301 | K052468 | 000 |
| M3683H0201401 | K052468 | 000 |
| M3683H0202001 | K052468 | 000 |
| M3683H0202201 | K052468 | 000 |
| M3683H0203201 | K052468 | 000 |
| 00822383140490 | K052468 | 000 |