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Deka Arm System

by Deka Integrated Solutions Corporation De Novo

Active United States

De Novo DEN120016

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Post-NSE NumberDEN120016 Date9 May 2014DecidedStatusActive

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  • Withdrawn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 11 Oct 2026.

Specification

De Novo

De Novo Number
FDA Product Code
PAE
Device Class
Class II
Regulation
21 CFR Part 890.3450
Advisory Committee
Physical Medicine
FDA Decision
DENG De Novo granted