Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1422443

FEI Number

1000143485

Entity Name

DMS HOLDINGS, INC.,

City/State/Country

Waukegan, IL, US

Establishment Address

Dba/Healthsmart International, 1931 Norman Dr, Waukegan, IL 60085, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

DMS HOLDINGS DBA HealthSmart International (Owner Number: 9005245)

Owner / Operator Contact Address

1931 NORMAN DR., --, Waukegan, IL 60085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SwitchStick DMI DMI DMI DMI DMI DMI DMI Heelbo L-Bow Arm Restraint DMI Mabis MABIS HEALTHSMART DMI Heelbo DMI Heelbo Inch Limb Restraint DMI DMI HealthSmart DMI DMI Mabis DMI HealthSmart DMI DMI Heelbo DMI DMI DMI HealthSmart Heelbo Heelbo Heelbo DMI Mabis DMI DMI DMI HealthSmart DMI DMI DMI DMI DMI DMI Mabis DMI Stein's DMI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPS	Cane	Physical Medicine	Class 1	890.3075	2006-02-16
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2007-08-14
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2023-08-31
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2023-09-01
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2006-02-16
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2023-09-01
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2007-08-14
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2008-02-28
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2007-08-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-01-09
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	1994-04-01
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2021-05-27
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	1994-05-05
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2008-02-28
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2023-09-06
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2020-06-29
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2023-08-31
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2023-09-06
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2023-09-01
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2014-05-22
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2023-09-01
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2007-08-14
FPS	Board, Bed	General Hospital	Class 1	880.6070	2007-08-14
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2023-09-01
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2006-02-16
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2011-05-13
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2007-08-14
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2023-08-31
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2008-02-28
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2021-05-27
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	1994-03-22
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2007-08-14
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2006-02-16
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2023-09-01
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2023-09-06
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2023-08-31
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2007-08-14
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2023-09-01
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2007-08-14
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-06-27
INF	Scale, Platform, Wheelchair	Physical Medicine	Class 1	890.3940	2023-08-31
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2023-09-01
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2023-08-31
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2023-09-01
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2023-08-31
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2023-09-01

Official Correspondent

Jerry Esses

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DMS HOLDINGS DBA HealthSmart International

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
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1422443. Last updated year: 2026. Please use registration number 1422443 when referencing this establishment in official correspondence.