The following data is part of a premarket notification filed by Electric Mobility Corp. with the FDA for Appollo Bath.
Device ID | K882669 |
510k Number | K882669 |
Device Name: | APPOLLO BATH |
Classification | Transport, Patient, Powered |
Applicant | ELECTRIC MOBILITY CORP. #1 MOBILITY PLAZA Sewell, NJ 08080 |
Contact | Joseph Surace |
Correspondent | Joseph Surace ELECTRIC MOBILITY CORP. #1 MOBILITY PLAZA Sewell, NJ 08080 |
Product Code | ILK |
CFR Regulation Number | 890.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-27 |
Decision Date | 1988-07-08 |