The following data is part of a premarket notification filed by Well Home Health Products Co. with the FDA for Wh Convertible Lightweght Wheelchair, Model Whl100.
Device ID | K060251 |
510k Number | K060251 |
Device Name: | WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100 |
Classification | Wheelchair, Mechanical |
Applicant | WELL HOME HEALTH PRODUCTS CO. NO. 58 FU-CHIUN ST. Hsin-chu City, TW |
Contact | Ke-min Jen |
Correspondent | Ke-min Jen WELL HOME HEALTH PRODUCTS CO. NO. 58 FU-CHIUN ST. Hsin-chu City, TW |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-31 |
Decision Date | 2006-03-08 |
Summary: | summary |