Data / Medical devices / United States / DMS Holdings, Inc.
DMS Holdings, Inc.: FDA-registered device maker in Waukegan, IL, United States, 7 510(k) clearances
DMS Holdings, Inc. is registered with the FDA (registration 1422443) in Waukegan, IL, United States. It lists 61 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 28, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1422443
- FEI number
- 1000143485
- Address
- Dba/Healthsmart International 1931 Norman Dr, Waukegan, IL, United States, 60085
- Owner or operator
- DMS HOLDINGS DBA HealthSmart International (9005245)
- Roles
- Complaint file establishment
- First device listed
- March 22, 1994
- Registered through
- 2026
- Brand names listed
- CALIBER, CRYSTAL, DMI, HEALTHSMART, HealthSmart, Heelbo, Heelbo Chair Belt, Heelbo Inch Limb Restraint and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Adaptor, Hygiene | ILS | 1 | Complaint file establishment | accessdata.fda.gov |
| Aid, Transfer | IKX | 1 | Complaint file establishment | accessdata.fda.gov |
| Apparatus, Traction, Non-Powered | HST | 1 | Complaint file establishment | accessdata.fda.gov |
| Attachment, Commode, Wheelchair | INB | 1 | Complaint file establishment | accessdata.fda.gov |
| Bag, Ice | KYR | 1 | Complaint file establishment | accessdata.fda.gov |
| Band Or Belt, Pelvic Support | ISR | 1 | Complaint file establishment | accessdata.fda.gov |
| Bed, Manual | FNJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Complaint file establishment | accessdata.fda.gov |
| Bedpan | FOB | 1 | Complaint file establishment | accessdata.fda.gov |
| Belt, Wheelchair | IQB | 1 | Complaint file establishment | accessdata.fda.gov |
| Binder, Abdominal | FSD | 1 | Complaint file establishment | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Complaint file establishment | accessdata.fda.gov |
| Board, Bed | FPS | 1 | Complaint file establishment | accessdata.fda.gov |
| Bottle, Hot/Cold Water | FPF | 1 | Complaint file establishment | accessdata.fda.gov |
| Cane | IPS | 1 | Complaint file establishment | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Complaint file establishment | accessdata.fda.gov |
| Chair And Table, Medical | KMN | 1 | Complaint file establishment | accessdata.fda.gov |
| Components, Exercise | IOD | 1 | Complaint file establishment | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment | accessdata.fda.gov |
| Cover, Cast | KIA | 1 | Complaint file establishment | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Complaint file establishment | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Complaint file establishment | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Complaint file establishment | accessdata.fda.gov |
| Device, Incontinence, Urosheath Type, Non-Sterile | NNX | 1 | Complaint file establishment | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Dispenser, Solid Medication | NXB | 1 | Complaint file establishment | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Complaint file establishment | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Complaint file establishment | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Complaint file establishment | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Complaint file establishment | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Complaint file establishment | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Complaint file establishment | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Complaint file establishment | accessdata.fda.gov |
| Orthosis, Abdominal | KTD | 1 | Complaint file establishment | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Complaint file establishment | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Complaint file establishment | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Complaint file establishment | accessdata.fda.gov |
| Pill Crusher/Cutter | OHY | 1 | Complaint file establishment | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Complaint file establishment | accessdata.fda.gov |
| Restraint, Protective | FMQ | 1 | Complaint file establishment | accessdata.fda.gov |
| Restraint, Wheelchair, Non-Protective | KID | 1 | Complaint file establishment | accessdata.fda.gov |
| Scale, Platform, Wheelchair | INF | 1 | Complaint file establishment | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Complaint file establishment | accessdata.fda.gov |
| Shoe, Cast | IPG | 1 | Complaint file establishment | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Complaint file establishment | accessdata.fda.gov |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 | Complaint file establishment | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Complaint file establishment | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Complaint file establishment | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Complaint file establishment | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Complaint file establishment | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Complaint file establishment | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Complaint file establishment | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment | accessdata.fda.gov |
| Table, Mechanical | INW | 1 | Complaint file establishment | accessdata.fda.gov |
| Tips And Pads, Cane, Crutch And Walker | INP | 1 | Complaint file establishment | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Complaint file establishment | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Complaint file establishment | accessdata.fda.gov |
| Utensil, Eating | ILC | 1 | Complaint file establishment | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| November 28, 2022 | K222652 | Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer | DXQ | Substantially Equivalent | Cardicare Company, Ltd. | accessdata.fda.gov |
| November 17, 2016 | K161735 | Non-contact Forehead Thermometer | FLL | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
| April 13, 2012 | K120032 | MECHANICAL WHEELCHAIR | IOR | Substantially Equivalent | Aikin Healthcare Co., Ltd. | accessdata.fda.gov |
| October 18, 1996 | K962834 | HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP | FMQ | Substantially Equivalent | Heelbo, Inc. | accessdata.fda.gov |
| October 18, 1996 | K962831 | THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE | FMQ | Substantially Equivalent | Heelbo, Inc. | accessdata.fda.gov |
| October 9, 1996 | K962778 | THE L-BOW ARM RESTRAINT | FMQ | Substantially Equivalent | Heelbo, Inc. | accessdata.fda.gov |
| July 14, 1995 | K942543 | ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS | DXN | Substantially Equivalent | Sankei Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|
| June 5, 2014 | 64774 | Class II | Terminated | DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking | There have been 5 customer reports of a series DMI Rollator Transport Chair collapsing during use. | accessdata.fda.gov |
Compare with other makers
Updated November 28, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.