Data / Medical devices / United States / Mueller Sports Medicine, Inc.
Mueller Sports Medicine, Inc.: FDA-registered device maker in Prairie Du Sac, WI, United States, 2 510(k) clearances
Mueller Sports Medicine, Inc. is registered with the FDA (registration 2110420) in Prairie Du Sac, WI, United States. It lists 27 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 15, 2019. 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
- 2110420
- Address
- One Quench DR., Prairie Du Sac, WI, United States, 53578
- Owner or operator
- MUELLER SPORTS MEDICINE, INC. (2110420)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 16, 1992
- Registered through
- 2026
- Brand names listed
- 1.5" ATHLETIC TAPE, 1.5" PERFORM TAPE (32 ROLLS), 1.5" X 15YD PERFORM PLUS TAPE (32 ROLLS), 2 PK WHITE TAPE 1.5" X 15 YD SHRINK WRAP, 2" MLASTIC TAPE (24 ROLLS), 2" PERFORM TAPE (24 ROLLS), 2" X 15YD PERFORM PLUS TAPE (24 ROLLS), 2PK LIME GREEN TAPE 1.5"X10YD SHRNK WRAP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Ice | KYR | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Band Or Belt, Pelvic Support | ISR | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Splint, Extremity, Inflatable, External | FZF | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Splint, Intranasal Septal | LYA | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Support, Scrotal, Therapeutic | FQJ | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Vapocoolant Device | MLY | U | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 15, 2019 | K190493 | Recovery Pump, 737R (RPX) | IRP | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| January 27, 2017 | K163280 | RP Lite 760R | IRP | Substantially Equivalent | Mego Afek AC , 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 18, 2020 | 85884 | Class II | Terminated | Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box | Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex". | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Band Or Belt, Pelvic Support
- All makers of Orthosis, Lumbar
- All makers of Stocking, Medical Support (For General Medical Purposes)
- All makers of Bandage, Elastic
- All makers of Massager, Powered Inflatable Tube
Updated May 15, 2019. 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.