Nova Ortho-Med Inc

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0131-2025Class IIBrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD PAugust 26, 2024
Z-0129-2025Class IIBrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL August 26, 2024
Z-0130-2025Class IIBrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PLAugust 26, 2024
Z-0654-2021Class IIStar 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)October 7, 2019
Z-0304-2017Class II4205 Journey Rolling Walker Product Usage: used to assist people in walkingOctober 1, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K0612737000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200LMay 23, 2006