The following data is part of a premarket notification filed by Lossing Orthopedic, Inc. with the FDA for Back Saver Lift Belt/wheelchair Transfer Device.
Device ID | K864152 |
510k Number | K864152 |
Device Name: | BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE |
Classification | Transport, Patient, Powered |
Applicant | LOSSING ORTHOPEDIC, INC. 777 HARDING STREET, N.E. M-4 P.O. BOX 18298 Minneapolis, MN 55418 |
Contact | Susan G Wolf |
Correspondent | Susan G Wolf LOSSING ORTHOPEDIC, INC. 777 HARDING STREET, N.E. M-4 P.O. BOX 18298 Minneapolis, MN 55418 |
Product Code | ILK |
CFR Regulation Number | 890.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-23 |
Decision Date | 1987-02-05 |