The following data is part of a premarket notification filed by Jan Mao Industries Co., Ltd. with the FDA for Jan Mao Wheelchair, Models Jmc612-fl318epp And Jmc612-fl418epp.
| Device ID | K062218 |
| 510k Number | K062218 |
| Device Name: | JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP |
| Classification | Wheelchair, Mechanical |
| Applicant | JAN MAO INDUSTRIES CO., LTD. NO. 58 FU-CHIUN ST. Hsin-chu City, TW 300 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen JAN MAO INDUSTRIES CO., LTD. NO. 58 FU-CHIUN ST. Hsin-chu City, TW 300 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-01 |
| Decision Date | 2006-08-16 |
| Summary: | summary |