The following data is part of a premarket notification filed by Line Ind.(shanghai) Co., Ltd. with the FDA for Mini Power Chair, Model Mn 5000.
Device ID | K062483 |
510k Number | K062483 |
Device Name: | MINI POWER CHAIR, MODEL MN 5000 |
Classification | Wheelchair, Powered |
Applicant | LINE IND.(SHANGHAI) CO., LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
Contact | Sid Mathur |
Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2006-08-25 |
Decision Date | 2006-09-08 |
Summary: | summary |