510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NXEClass I

Walker, Mechanical, Poly Vinyl Chloride (Pvc)

21 CFR 890.3825 / Physical Medicine
FDA source (opens on fda.gov)

NXE is the FDA product code for Walker, Mechanical, Poly Vinyl Chloride (Pvc), a class I device type, regulated under 21 CFR 890.3825. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NXE
Device name
Walker, Mechanical, Poly Vinyl Chloride (Pvc)
FDA definition
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.
Regulation
21 CFR 890.3825
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NXE

By decision year
1 clearance under product code NXE with a decision year between 2005 and 2005, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NXE by decision year
YearClearances
20051

Applicants with the most clearances

Product code NXE
Applicants holding the most 510(k) clearances under product code NXE
ApplicantClearances
MJM International Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code