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Sign in to claim this brandPerformance Health Supply, LLC
United States·US-MF-000003318
Last updated May 24, 2026
What Performance Health Supply, LLC makes
Performance Health Supply, LLC manufactures a range of medical products including single-use transcutaneous electrical stimulation electrodes, acupuncture needles, and electric pad localized-body heating systems. Their portfolio also features drug-delivery iontophoresis patches, skin topical coupling gels, clinical external manual massagers, physical therapy paraffin wax baths, and aneroid manual sphygmomanometers. Additionally, the company produces various patient support and assistive items such as gel padding, stockinette materials, and specialized grip utensils.
The company is based in the United States and maintains a portfolio consisting of Class I and Class II medical devices. These products are listed in the FDA UDI database and EUDAMED to ensure regulatory compliance and transparency.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Performance Health Supply, LLC primarily manufacture?
Performance Health Supply, LLC specializes in a variety of medical devices, including single-use transcutaneous electrical stimulation electrodes, acupuncture needles, and localized-body heating systems. Their portfolio also includes drug-delivery iontophoresis patches, topical coupling gels for skin, clinical external manual massagers, paraffin wax baths for physical therapy, and aneroid manual sphygmomanometers. Additionally, they produce patient support items like gel padding and stockinette materials, as well as assistive utensils designed for easier handling.
Where is Performance Health Supply, LLC based, and what regulatory databases list their devices?
Performance Health Supply, LLC is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database and EUDAMED, which are key registries for tracking medical devices in the U.S. and European Union, respectively. Listing in these databases helps ensure compliance with regulatory requirements and transparency for healthcare providers.
How are the devices manufactured by Performance Health Supply, LLC classified under medical device regulations?
The devices produced by Performance Health Supply, LLC fall into two primary regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve a higher level of risk and typically require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with.
Are the devices listed in Performance Health Supply, LLC’s portfolio used for therapeutic or diagnostic purposes?
Performance Health Supply, LLC’s devices serve a mix of therapeutic and supportive purposes. Therapeutic devices in their portfolio include transcutaneous electrical stimulation electrodes, acupuncture needles, iontophoresis patches, heating systems, and physical therapy tools like paraffin wax baths and massagers. Meanwhile, items like gel padding, stockinette, and assistive utensils are designed to support patient comfort, mobility, and independence rather than diagnose or treat medical conditions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- W68 N158, Evergreen Blvd, Cedarburg, United States
- Website
- performancehealth.com
- —
- —
- [email protected]
- Phone
- +1 331 688 9688
- PRRC Contact
- Melanie Leibowitz
- EUDAMED SRN
- US-MF-000003318
- FDA FEI Number
- —
- DUNS Number
- 966806150
Catalogue (482)
Page 1 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Rolyan Gel Padding, 3/16" (4.8mm) | 081288968 | EUDAMED | Class I | Active |
| Sammons Preston Sure Grip Utensils, Fork | 081287937 | EUDAMED | Class I | Active |
| Rolyan Cotton Stockinette, 4" x 25yds (10.2cm x 22.9m), Natural | 081187053 | EUDAMED | Class I | Active |
| Sammons Preston Sure Grip Bendable Utensils, Rocker Knife | 081288000 | EUDAMED | Class I | Active |
| Rolyan Cotton Stockinette, 3" x 25yds (7.6cm x 22.9m), Natural | 081187046 | EUDAMED | Class I | Active |
| Rolyan Gel Padding, 1/4" (6.4mm) | 081288976 | EUDAMED | Class I | Active |
| Sammons Preston Sure Grip Bendable Utensils, Tablespoon | 081287986 | EUDAMED | Class I | Active |
| Rolyan Cotton/Polyester Stockinette, White, 3" X 25yds(7.6cm X 23m), 1/Ea | 081286194 | EUDAMED | Class I | Active |
| Rolyan Cotton Stockinette, 6" x 25yds (15.2cm x 22.9m), Natural | 081187061 | EUDAMED | Class I | Active |
| Rolyan Cotton/Polyester Stockinette, White, 4" X 25yds(10.2cm X 23m), 1/Ea | 081286202 | EUDAMED | Class I | Active |
| Sammons Preston Sure Grip Utensils, Knife | 081287945 | EUDAMED | Class I | Active |
| Rolyan Gel Padding, 1/8" (3.2mm) | 081288950 | EUDAMED | Class I | Active |
| Sammons Preston Sure Grip Bendable Utensils, Fork | 081287994 | EUDAMED | Class I | Active |
| Sammons Preston Sure Grip Bendable Utensils, Teaspoon | 081287978 | EUDAMED | Class I | Active |
| Sammons Preston Sure Grip Utensils, Teaspoon | 081287911 | EUDAMED | Class I | Active |
| Large Tf Weighted Vest Blue | 081115898 | EUDAMED | Class I | Active |
| En Rolyan Cotton/Polyester Stockinette, White, 2" X 25yds(5.1cm X 23m), 1/Ea | 081286186 | EUDAMED | Class I | Active |
| Sammons Preston Sure Grip Utensils, Tablespoon | 081287929 | EUDAMED | Class I | Active |
| Performance Health | 081071695 | FDA UDI | Class II | Active |
| Performance Health | 081071331 | FDA UDI | Class II | Active |
| Performance Health | 7101429 | FDA UDI | Class II | Active |
| Performance Health | 081071265 | FDA UDI | Class II | Active |
| Performance Health | 081071570 | FDA UDI | Class II | Active |
| Performance Health | 081214220 | FDA UDI | Class II | Active |
| Performance Health | 081703511 | FDA UDI | Class II | Active |
| Rolyan | 081296003 | FDA UDI | Class I | Active |
| Performance Health | 081214212 | FDA UDI | Class II | Active |
| Performance Health | 081071562 | FDA UDI | Class II | Active |
| Performance Health | 081703545 | FDA UDI | Class II | Active |
| Performance Health | 7101427 | FDA UDI | Class II | Active |
| Performance Health | 081703685 | FDA UDI | Class II | Active |
| Performance Health | 081071729 | FDA UDI | Class II | Active |
| Performance Health | 081086537 | FDA UDI | Class II | Active |
| Performance Health | 7102313 | FDA UDI | Class II | Active |
| Performance Health | 7100695 | FDA UDI | Class II | Active |
| Patterson Medical | 568707 | FDA UDI | Class II | Unknown |
| Performance Health | 081071711 | FDA UDI | Class II | Active |
| Sammons Preston | 7011159 | FDA UDI | Class II | Active |
| Performance Health | 081071620 | FDA UDI | Class II | Active |
| Performance Health | 081071661 | FDA UDI | Class II | Active |
| Performance Health | 081703677 | FDA UDI | Class II | Active |
| Performance Health | 081703503 | FDA UDI | Class II | Active |
| Performance Health | 081214402 | FDA UDI | Class II | Active |
| Performance Health | 081071703 | FDA UDI | Class II | Active |
| Performance Health | 081703651 | FDA UDI | Class II | Active |
| Performance Health | 081214329 | FDA UDI | Class II | Active |
| Performance Health | 081301001 | FDA UDI | Class II | Active |
| Sammons Preston | 7011158 | FDA UDI | Class II | Active |
| Performance Health | 081214204 | FDA UDI | Class II | Active |
| Sammons Preston | O81505940 | FDA UDI | Class II | Active |
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