The following data is part of a premarket notification filed by R. Poon Medical Products Co., Ltd. with the FDA for R. Poon Medical Products Wheelchairs.
Device ID | K050691 |
510k Number | K050691 |
Device Name: | R. POON MEDICAL PRODUCTS WHEELCHAIRS |
Classification | Wheelchair, Mechanical |
Applicant | R. POON MEDICAL PRODUCTS CO., LTD. 10 NEWTON PLACE Hauppauge, NY 11788 |
Contact | Richard Graver |
Correspondent | Richard Graver R. POON MEDICAL PRODUCTS CO., LTD. 10 NEWTON PLACE Hauppauge, NY 11788 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-17 |
Decision Date | 2005-04-21 |