The following data is part of a premarket notification filed by Merits Health Products., Inc. with the FDA for Travel Ease Electric Scooter, Model Pioneer 4.
Device ID | K011753 |
510k Number | K011753 |
Device Name: | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | MERITS HEALTH PRODUCTS., INC. P.O. BOX 150356 Cape Coral, FL 33915 |
Contact | Winston Anderson |
Correspondent | Winston Anderson MERITS HEALTH PRODUCTS., INC. P.O. BOX 150356 Cape Coral, FL 33915 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-06 |
Decision Date | 2001-08-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04714379291834 | K011753 | 000 |
04714379291803 | K011753 | 000 |
04714379291797 | K011753 | 000 |
04714379291766 | K011753 | 000 |
04714379291759 | K011753 | 000 |
04714379291742 | K011753 | 000 |
04714379291186 | K011753 | 000 |
04714379291124 | K011753 | 000 |
04714379291117 | K011753 | 000 |