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
DEN230015Unknown

Osteoboost Belt

Bone Health Technologies, Redwood City CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN230015 is the FDA 510(k) clearance record for Osteoboost Belt, a class II device, cleared for Bone Health Technologies, Inc. on under FDA product code QZO (Wearable Vibration Device For Orthopedic Use). FDA's definition for product code QZO 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". FDA records list one 510(k) clearance for Bone Health Technologies, Inc. As of , FDA records show no recalls naming DEN230015.

Clearance record

Decision date
Received
(329 days to decision)
Product code
QZO Wearable Vibration Device For Orthopedic Use
Regulation
21 CFR 888.5895
Device class
Class II
Review panel
Orthopedic
Applicant
Bone Health Technologies, Inc. 370 Convention Way, Redwood City CA
Third party review
No

Clearances, product code QZO

Trailing 12 months

FDA records hold no clearances under product code QZO in the trailing twelve months.

FDA records show no clearances under product code QZO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QZO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260