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Sign in to claim this brandBROWNMED, INC.
United States·US-MF-000008271
Last updated May 23, 2026
What BROWNMED, INC. makes
BrownMed, Inc. manufactures reusable orthopedic and therapeutic devices, including hand and finger splints, waterproof bathing covers for casts and bandages, prefabricated orthotic insoles, ankle/foot orthoses, and suspension arm slings. Their product line also includes reusable hot/cold therapy packs, heel protectors, and hand-held vibration therapy units designed for circulatory and musculoskeletal support.
The company’s devices are classified under Class I and Class II regulations, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer operates from the United States.
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 BrownMed, Inc. manufacture?
BrownMed, Inc. specializes in reusable orthopedic and therapeutic devices. Their product line includes hand and finger splints for immobilization, waterproof bathing covers for casts and bandages to allow safe water exposure, prefabricated orthotic insoles for arch support, ankle/foot orthoses for alignment or cushioning, and suspension arm slings for shoulder support. They also produce reusable hot/cold therapy packs, heel protectors for pressure relief, and hand-held vibration therapy units targeting circulatory and musculoskeletal conditions.
Where is BrownMed, Inc. based, and how does that affect its devices?
BrownMed, Inc. is based in the United States. This location influences regulatory compliance, as their devices are listed in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and reporting requirements under U.S. regulations. Additionally, their products are also documented in the EU’s EUDAMED database, indicating their availability or distribution in the European market, though the company itself is not subject to EU regulatory approvals.
Which regulatory registries list BrownMed, Inc.’s devices?
BrownMed, Inc.’s devices are listed in two key regulatory registries: the EUDAMED database, which tracks medical devices marketed in the European Union, and the FDA’s Unique Device Identifier (UDI) system, which ensures device traceability and compliance in the United States. These listings help healthcare providers and regulators identify and verify the devices’ regulatory status.
How are BrownMed, Inc.’s devices classified under medical regulations?
BrownMed, Inc.’s devices fall under Class I and Class II classifications. Class I devices generally pose minimal risk and require general controls (e.g., good manufacturing practices), while Class II devices involve a higher level of risk and may require additional performance standards or post-market surveillance. The classification determines the regulatory scrutiny and labeling requirements for each product.
Why do some of BrownMed’s devices require special care, like waterproofing or reusability?
Several of BrownMed’s devices are designed for reusability (e.g., splints, bathing covers, and therapy packs) to reduce waste and cost for patients and healthcare systems. The waterproof bathing covers for casts and bandages are specifically engineered to allow patients to safely bathe or swim without damaging the immobilization, which is critical for maintaining hygiene and preventing infections. These features align with practical patient needs while adhering to regulatory standards for reusable medical devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1300, Lundberg Drive West, Spirit Lake, United States
- Website
- brownmed.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Brandon Rodriguez
- EUDAMED SRN
- US-MF-000008271
- FDA FEI Number
- —
- DUNS Number
- 091999771
Catalogue (432)
Page 8 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Plastalume | SP10410-25 | FDA UDI | Class I | Active |
| Polar Ice | 30036 | FDA UDI | Class I | Active |
| Spark | 40428 | EUDAMEDFDA UDI | Class I | Active |
| Plastalume | 10008 | EUDAMEDFDA UDI | Class I | Active |
| Plastalume | 10030 | EUDAMEDFDA UDI | Class I | Active |
| Soft Stride | 71423 | EUDAMEDFDA UDI | Class I | Active |
| Plastalume | SP10447-25 | FDA UDI | Class I | Active |
| Plastalume | 10612 | EUDAMEDFDA UDI | Class I | Active |
| Plastalume | 10332 | FDA UDI | Class I | Active |
| NuRoo | 08008 | FDA UDI | Class I | Unknown |
| Soft Stride | 71363 | EUDAMEDFDA UDI | Class I | Active |
| Joslin | J50701ZL | FDA UDI | Class I | Active |
| Soft Stride | 71342 | EUDAMEDFDA UDI | Class I | Active |
| Intellinetix | 07238 | FDA UDI | Class I | Active |
| Seal-Tight | 28002 | EUDAMEDFDA UDI | Class I | Active |
| Steady Step | 50086 | FDA UDI | Class I | Active |
| Plastalume | 10736 | EUDAMEDFDA UDI | Class I | Active |
| Plastalume | 10821 | EUDAMEDFDA UDI | Class I | Active |
| Sea-Tight | 20325 | EUDAMEDFDA UDI | Class I | Active |
| Soft Stride | 71341 | EUDAMEDFDA UDI | Class I | Active |
| Spark | 40421 | EUDAMEDFDA UDI | Class I | Active |
| Joslin | J50001CS | FDA UDI | Class I | Active |
| Joslin | J50501ZL | FDA UDI | Class I | Active |
| Seal-Tight | 28075 | EUDAMEDFDA UDI | Class I | Active |
| Steady Step | 50164 | FDA UDI | Class I | Active |
| Steady Step | 50051 | FDA UDI | Class I | Active |
| Intellinetix | 07105 | FDA UDI | Class II | Active |
| Plastalume | 10326 | EUDAMEDFDA UDI | Class I | Active |
| Plastalume | 15011 | FDA UDI | Class I | Active |
| Seal-Tight | 20411 | FDA UDI | Class I | Active |
| Plastalume | 10322 | FDA UDI | Class I | Active |
| Seal-Tight | 20105 | EUDAMEDFDA UDI | Class I | Active |
| Plastalume | 12523 | FDA UDI | Class I | Active |
| Plastalume | 10704 | FDA UDI | Class I | Active |
| Nice Stretch | 53101 | EUDAMEDFDA UDI | Class I | Active |
| Plastalume | 12023 | FDA UDI | Class I | Active |
| Plastalume | SP10436-25 | FDA UDI | Class I | Active |
| IMAK Compression | A20172 | FDA UDI | Class I | Active |
| Plastalume | SP10444-25 | FDA UDI | Class I | Active |
| Seal-Tight | 26501 | EUDAMEDFDA UDI | Class I | Active |
| Soft Stride | 71439 | FDA UDI | Class I | Active |
| Plastalume | 10101 | EUDAMEDFDA UDI | Class I | Active |
| Soft Stride | 71312 | EUDAMEDFDA UDI | Class I | Active |
| Imak Rsi | 60500 | FDA UDI | Class I | Active |
| IMAK Ergo | A30111 | EUDAMEDFDA UDI | Class I | Active |
| Nice Stretch | 51030 | FDA UDI | Class I | Active |
| Plastalume | 10602 | EUDAMEDFDA UDI | Class I | Active |
| Plastalume | 10110 | FDA UDI | Class I | Active |
| Polar Ice | 30105 | EUDAMEDFDA UDI | Class I | Active |
| IMAK Compression | A20192 | FDA UDI | Class I | Active |
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