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Osteoboost Belt

by Bone Health Technologies, Inc. De Novo

Active United States

De Novo DEN230015

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN230015 Date12 Jan 2024DecidedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

De Novo

De Novo Number
FDA Product Code
QZO
Device Class
Class II
Regulation
21 CFR Part 888.5895
Advisory Committee
Orthopedic
FDA Decision
DENG De Novo granted