The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Battery Powered Patient Lift.
Device ID | K840997 |
510k Number | K840997 |
Device Name: | BATTERY POWERED PATIENT LIFT |
Classification | Lift, Patient, Non-ac-powered |
Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 |
Product Code | FSA |
CFR Regulation Number | 880.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-08 |
Decision Date | 1984-04-17 |