NXEClass I
Walker, Mechanical, Poly Vinyl Chloride (pvc)
Physical Medicine · 21 CFR 890.3825
This type of mechanical walker is a four-legged device with a poly vinyl chloride (pvc) frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.
MDR events11All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances1All time
Recent MDR events
11 adverse event reports on file
- GUARDIAN EASY CARE WALKERAug 2, 2019InjurySunrise Medical (us) Llc2937137-2019-00021
- DRIVE MEDICALFeb 14, 2013InjuryFoshan R Poon Medical Products Co, Ltd2438477-2013-00005
- DRIVE MEDICALOct 4, 2012InjuryUnk2438477-2012-00022
- DRIVE MEDICALJun 7, 2012InjuryShanghai Shunlong Physical Therapy Equipment Co.3003910843-2012-00002
- DRIVE MEDICALMay 31, 2012InjuryShanghai Shunlong Physical Therapy Equipment Co.2438477-2012-00010
- DRIVE MEDICALMay 18, 2012InjuryMaxhealth Corp2438477-2012-00009
- DRIVE MEDICALApr 27, 2012InjuryUnknown2438477-2012-00007
- DRIVER MEDICALAug 10, 2007InjuryMedical Depot Inc. (d/b/a Drive Medical Design And Mfg)2438477-2007-00002
- DRIVE MEDICALJun 8, 2007InjuryMedical Depot Inc. (d/b/a Drive Medical Design & Mfg)2438477-2007-00001
- WALKER, RIGID, NON FOLDINGFeb 19, 2007MalfunctionMedline Industries, Inc.1417592-2007-00010
Event type breakdown
Injury10
Malfunction1
Most-reported manufacturers
Shanghai Shunlong Physical Therapy Equipment Co.2Foshan R Poon Medical Products Co, Ltd1Maxhealth Corp1Medical Depot Inc. (d/b/a Drive Medical Design & Mfg)1Medical Depot Inc. (d/b/a Drive Medical Design And Mfg)1Medical Depot, Inc (d/b/a Drive Medical Design & Mfg)1Medline Industries, Inc.1Sunrise Medical (us) Llc1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
1 clearances for this product code