510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QZOClass II

Wearable Vibration Device For Orthopedic Use

21 CFR 888.5895 / Orthopedic
FDA source (opens on fda.gov)

QZO is the FDA product code for Wearable Vibration Device For Orthopedic Use, a class II device type, regulated under 21 CFR 888.5895. FDA's definition for this code reads: "A wearable vibration device for orthopedic use is a wearable device that uses mechanical vibrations, targeted to specific regions of the skeleton, to reduce loss of bone strength or bone mineral density". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QZO
Device name
Wearable Vibration Device For Orthopedic Use
FDA definition
A wearable vibration device for orthopedic use is a wearable device that uses mechanical vibrations, targeted to specific regions of the skeleton, to reduce loss of bone strength or bone mineral density.
Regulation
21 CFR 888.5895
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QZO

By decision year
1 clearance under product code QZO with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QZO by decision year
YearClearances
20241

Applicants with the most clearances

Product code QZO
Applicants holding the most 510(k) clearances under product code QZO
ApplicantClearances
Bone Health Technologies1

Companies listing this code with FDA

Companies whose registered establishments list this code