Data / Medical devices / United States / Sunrise Medical (US) LLC
Sunrise Medical (US) LLC: FDA-registered device maker in Mount Juliet, TN, United States, 16 510(k) clearances
Sunrise Medical (US) LLC is registered with the FDA (registration 3019677893) in Mount Juliet, TN, United States. It lists 21 device types. The FDA files 16 510(k) clearances under its listings, the newest dated December 10, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3019677893
- Address
- 12002 Volunteer Blvd, Mount Juliet, TN, United States, 37122
- Owner or operator
- Sunrise Medical (US) LLC (9019832)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 7, 1992
- Registered through
- 2026
- Brand names listed
- Advance Bath Chair, BeMe Seating System, CTRL+5, Cool Cube, Dual Pro, Early Activity System, Empulse F35, Empulse M90 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Adaptor, Hygiene | ILS | 1 | Manufacturer | accessdata.fda.gov |
| Aid, Transfer | IKX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Armrest, Wheelchair | IML | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Belt, Wheelchair | IQB | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Board, Lap, Wheelchair | IMX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Brake, Extension, Wheelchair | IMW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Chair, With Casters | INM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Device, Anti-Tip, Wheelchair | IMR | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Footrest, Wheelchair | IMM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Handrim, Wheelchair | IMO | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Holder, Crutch And Cane, Wheelchair | IMZ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Specification developer | accessdata.fda.gov |
| Support, Head And Trunk, Wheelchair | IMS | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wheelchair, Standup | IPL | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 10, 2024 | K242327 | Empulse M90 | ITI | Substantially Equivalent | Concourse Assistive Technology Pty, Ltd. | accessdata.fda.gov |
| March 4, 2024 | K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | ITI | Substantially Equivalent | Magic Mobility | accessdata.fda.gov |
| May 12, 2022 | K220740 | Power Wheelchair, W5907 (Q50 R Carbon) | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| March 30, 2022 | K220213 | Empulse R90 | ITI | Substantially Equivalent | Sunrise Medical (Us), LLC | accessdata.fda.gov |
| November 19, 2021 | K213090 | Frontier Series Power Wheelchairs | ITI | Substantially Equivalent | Magic Mobility | accessdata.fda.gov |
| July 9, 2021 | K211574 | Extreme X8 | ITI | Substantially Equivalent | Magic Mobility | accessdata.fda.gov |
| March 17, 2021 | K203083 | Magic 360 Power Wheelchair | ITI | Substantially Equivalent | Magic Mobility | accessdata.fda.gov |
| January 16, 2018 | K172384 | Quickie(r) Q700-UP M | IPL | Substantially Equivalent | Sunrise Medical (Us), LLC | accessdata.fda.gov |
| December 18, 2014 | K142457 | Quickie, Zippie | ITI | Substantially Equivalent | Sunrise Medical (Us), LLC | accessdata.fda.gov |
| August 16, 2013 | K123975 | QUICKIE & ZIPPIE SERIES | IOR | Substantially Equivalent | Sunrise Medical | accessdata.fda.gov |
| April 10, 2009 | K090350 | EXTREME 4X4-X8 POWER WHEELCHAIR | ITI | Substantially Equivalent | Vestil Manufacturing Corp. | accessdata.fda.gov |
| September 10, 2007 | K072153 | QUICKIE QX MANUAL FOLDING WHEELCHAIR | IOR | Substantially Equivalent | Sunrise Medical, Inc. | accessdata.fda.gov |
| December 15, 2000 | K001491 | QUICKIE 2 POWER ASSIST WHEELCHAIR | ITI | Substantially Equivalent | Sunrise Medical, Inc. | accessdata.fda.gov |
| October 25, 1998 | K983639 | ZIPPIE GS, MODEL # EIZGS | IOR | Substantially Equivalent | Sunrise Medical, Inc. | accessdata.fda.gov |
| November 20, 1997 | K973673 | QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES | IOR | Substantially Equivalent | Sunrise Medical, Inc. | accessdata.fda.gov |
| July 6, 1995 | K952641 | QUICKIE TSR | IOR | Substantially Equivalent | Sunrise Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Mechanical
- All makers of Device, Anti-Tip, Wheelchair
- All makers of Wheelchair, Powered
- All makers of Walker, Mechanical
- All makers of Aid, Transfer
- All makers of Footrest, Wheelchair
Updated December 10, 2024. 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.