510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN120016Unknown

Deka Arm System

Deka Integrated Solutions Corporation, Manchester NH / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN120016 is the FDA 510(k) clearance record for DEKA ARM SYSTEM, a class II device, cleared for Deka Integrated Solutions Corporation on under FDA product code PAE (Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography). FDA's definition for product code PAE reads: "Upper extremity prosthesis intended to replace partially or fully amputated or congenitally absent upper extremities and to provide multiple and simultaneous degrees of freedom and functionality". FDA records list one 510(k) clearance for Deka Integrated Solutions Corporation. As of , FDA records show no recalls naming DEN120016.

Clearance record

Decision date
Received
(693 days to decision)
Product code
PAE Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
Regulation
21 CFR 890.3450
Device class
Class II
Review panel
Physical Medicine
Applicant
Deka Integrated Solutions Corporation 340 Commercial St., Manchester NH
Third party review
No

Clearances, product code PAE

Trailing 12 months

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

FDA records show no clearances under product code PAE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PAE, 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