The following data is part of a premarket notification filed by Burke Mobility Products with the FDA for Pace Saver Little Jr.
Device ID | K925122 |
510k Number | K925122 |
Device Name: | PACE SAVER LITTLE JR |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | BURKE MOBILITY PRODUCTS P.O. BOX 1064 Mission, KS 66222 |
Contact | Duwayne E Kramer |
Correspondent | Duwayne E Kramer BURKE MOBILITY PRODUCTS P.O. BOX 1064 Mission, KS 66222 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-09 |
Decision Date | 1994-03-30 |