The following data is part of a premarket notification filed by Jan Mao Industries Co., Ltd. with the FDA for Jan Mao Wheelchair, Model Jmc612-f18epp.
Device ID | K051482 |
510k Number | K051482 |
Device Name: | JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP |
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 | 2005-06-03 |
Decision Date | 2005-06-29 |
Summary: | summary |