DEKA RESEARCH & DEVELOPMENT CORP.

FDA Device Registration & Listing · Manchester, NH, US · Registration 1220973

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1220973
FEI Number
1220973
Entity Name
DEKA RESEARCH & DEVELOPMENT CORP.
City/State/Country
Manchester, NH, US
Establishment Address
340 Commercial St, Manchester, NH 03101, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
DEKA Research & Development Corp. (Owner Number: 10041884)
Owner / Operator Contact Address
340 Commercial St, Manchester, NH 03101, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K093915
PMA Number
N/A

All Registered Proprietary Names

iBOT Personal Mobility Device (iBOT PMD) iBOT Volumetric Infusion Controller DEKA TAC Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QJY Infusion Pump, Drug Specific, Pharmacy-Filled General Hospital Class 2 880.5725 2020-07-22
ITI Wheelchair, Powered Physical Medicine Class 2 890.3860 2021-08-06
IMK Wheelchair, Stair Climbing Physical Medicine Class 2 890.3890 2021-08-06
FRN Pump, Infusion General Hospital Class 2 880.5725 2025-08-15
IMK Wheelchair, Stair Climbing Physical Medicine Class 2 890.3890 2018-11-30
QFG Alternate Controller Enabled Insulin Infusion Pump Clinical Chemistry Class 2 880.5730 2023-09-26
NDC Calculator, Drug Dose Anesthesiology Class 2 868.1890 2023-09-26
QJY Infusion Pump, Drug Specific, Pharmacy-Filled General Hospital Class 2 880.5725 2021-01-21
LDR Controller, Infusion, Intravascular, Electronic General Hospital Class 2 880.5725 2016-12-01
QFG Alternate Controller Enabled Insulin Infusion Pump Clinical Chemistry Class 2 880.5730 2025-08-15
ITI Wheelchair, Powered Physical Medicine Class 2 890.3860 2025-04-24
IMK Wheelchair, Stair Climbing Physical Medicine Class 2 890.3890 2025-04-24
QJI Interoperable Automated Glycemic Controller Clinical Chemistry Class 2 862.1356 2025-02-26
FRN Pump, Infusion General Hospital Class 2 880.5725 2020-07-22
FIG Clamp, Tubing, Blood, Automatic Gastroenterology, Urology Class 2 876.5820 2012-09-13

Official Correspondent

Paul Smolenski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEKA Research & Development Corp.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K853594 Vessa , Ltd. VESSA FLIVVA 1985-09-24
K142783 Heartway Medical Products Co., Ltd. HEARTWAY Electrically Powered Wheelchair P27 2015-06-12
K913718 Abbott Laboratories PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED 1991-10-30
K840616 Advanced Bio Systems, Inc. MINI-PUMP U-100 1984-03-30
K850183 Deltec Systems, Inc. CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M 1985-03-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.
Z-0022-05 Independence Technology LLC 2
iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1220973. Last updated year: 2026. Please use registration number 1220973 when referencing this establishment in official correspondence.
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