The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Ultra Iii.
Device ID | K960096 |
510k Number | K960096 |
Device Name: | ULTRA III |
Classification | Stimulator, Muscle, Powered |
Applicant | EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
Contact | John R Mumford |
Correspondent | John R Mumford EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
Product Code | IPF |
Subsequent Product Code | GZJ |
Subsequent Product Code | IMG |
Subsequent Product Code | IMI |
Subsequent Product Code | LIH |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-11 |
Decision Date | 1996-03-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ULTRA III 76305515 2671489 Dead/Cancelled |
PLASTIC SPECIALTIES MANUFACTURING, INC. 2001-08-28 |
![]() ULTRA III 76305514 2615027 Dead/Cancelled |
C&A PRO, LLC 2001-08-28 |