The following data is part of a premarket notification filed by Med-ez, Inc. with the FDA for Turn Ez Bed Device.
Device ID | K922473 |
510k Number | K922473 |
Device Name: | TURN EZ BED DEVICE |
Classification | Bed, Patient Rotation, Powered |
Applicant | MED-EZ, INC. 2400 GIBBS DR. Reidsville, NC 27320 |
Contact | Grady Bingham |
Correspondent | Grady Bingham MED-EZ, INC. 2400 GIBBS DR. Reidsville, NC 27320 |
Product Code | IKZ |
CFR Regulation Number | 890.5225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-26 |
Decision Date | 1992-09-09 |