The following data is part of a premarket notification filed by Aceme Technologies Intl. with the FDA for Aceme Jupiter Scooter, 3-wheeled, Model Jupiter 50.
Device ID | K983405 |
510k Number | K983405 |
Device Name: | ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | ACEME TECHNOLOGIES INTL. 5580 POWER INN RD., SUITE I Sacramento, CA 95820 |
Contact | Tong Zhou |
Correspondent | Tong Zhou ACEME TECHNOLOGIES INTL. 5580 POWER INN RD., SUITE I Sacramento, CA 95820 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-28 |
Decision Date | 1998-11-06 |
Summary: | summary |