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Sign in to claim this brandBlake Manufacturing, Inc.
US
Last updated May 23, 2026
What Blake Manufacturing, Inc. makes
Blake Manufacturing, Inc. produces custom and pre-fabricated orthotic devices, including wrist/hand orthoses, knee support orthoses, elbow orthoses, ankle/foot orthoses, and hip orthoses. Their portfolio includes devices such as the BMI series and the Panacea line, designed to provide support and stability for musculoskeletal conditions.
The company’s devices are classified under Class I by the FDA and are listed in the FDA’s Unique Device Identifier (UDI) database. Blake Manufacturing, Inc. is headquartered in 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 Blake Manufacturing, Inc. primarily manufacture?
Blake Manufacturing, Inc. specializes in orthotic devices designed to support and stabilize musculoskeletal conditions. Their portfolio includes wrist/hand orthoses, knee support orthoses, elbow orthoses, ankle/foot orthoses, and hip orthoses. These devices are tailored for patients requiring external support to aid mobility or recovery.
Where is Blake Manufacturing, Inc. based, and how does that affect their regulatory standing?
Blake Manufacturing, Inc. is headquartered in the United States. Since their devices are regulated under U.S. jurisdiction, they must comply with FDA requirements, including classification and UDI listing. The company’s location ensures alignment with U.S. regulatory frameworks for medical devices.
Which regulatory registries or databases list Blake Manufacturing, Inc.’s devices?
Blake Manufacturing, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify device details and compliance status. The UDI system is a key requirement for Class I devices in the U.S.
How are Blake Manufacturing, Inc.’s devices classified by regulatory authorities?
Blake Manufacturing, Inc.’s devices are classified under Class I by the FDA. This classification applies to low-risk orthotic devices that pose minimal potential harm to patients. Class I devices typically require general controls (like manufacturing practices and labeling) but do not require pre-market approval, as they are deemed safe and effective through established standards.
What does the FDA’s UDI listing mean for Blake Manufacturing, Inc.’s orthotic devices?
The FDA’s UDI (Unique Device Identifier) listing ensures that each of Blake Manufacturing, Inc.’s orthotic devices has a standardized identifier, combining a device identifier and a production identifier. This system improves patient safety, reduces medical errors, and enhances supply chain transparency by allowing healthcare providers to quickly access critical device information, such as manufacturer details and regulatory status, directly through the UDI database.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 103449711
Catalogue (325)
Page 1 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bmi | AFO-X | FDA UDI | Class I | Active |
| Bmi | HPR-PL | FDA UDI | Class I | Active |
| Bmi | HPR-RR | FDA UDI | Class I | Active |
| Panacea | DS-HTA-LL | FDA UDI | Class I | Active |
| Bmi | AFO-R-SB | FDA UDI | Class I | Active |
| Panacea | DS-HRX-LL | FDA UDI | Class I | Active |
| Panacea | DS-KNE-L | FDA UDI | Class I | Active |
| Bmi | AFO-RX | FDA UDI | Class I | Active |
| Panacea | DS-HRX-RL | FDA UDI | Class I | Active |
| Panacea | DS-HGR-LR | FDA UDI | Class I | Active |
| Panacea | DS-HRX-KH-PL | FDA UDI | Class I | Active |
| Bmi | ECO-SR | FDA UDI | Class I | Active |
| Panacea | DS-HRX-KH-LL | FDA UDI | Class I | Active |
| Bmi | HPA-PR | FDA UDI | Class I | Active |
| Panacea | DS-AFO-L-SB | FDA UDI | Class I | Active |
| Panacea | DS-KCO-XL | FDA UDI | Class I | Active |
| Panacea | DS-AFO-L | FDA UDI | Class I | Active |
| Bmi | KCO-XXR | FDA UDI | Class I | Active |
| Bmi | HRFM-PL | FDA UDI | Class I | Active |
| Bmi | ESO-XM | FDA UDI | Class I | Active |
| Panacea | DS-AFO-X-SB | FDA UDI | Class I | Active |
| Bmi | MSC-FM-R | FDA UDI | Class I | Active |
| Panacea | DS-MSC-AP | FDA UDI | Class I | Active |
| Panacea | DS-HTA-KH-LL | FDA UDI | Class I | Active |
| Bmi | KCA-XXL | FDA UDI | Class I | Active |
| Bmi | AFO-XL | FDA UDI | Class I | Active |
| Panacea | DS-HSG-RR | FDA UDI | Class I | Active |
| Panacea | DS-HRE-RL | FDA UDI | Class I | Active |
| Bmi | ECO-SL | FDA UDI | Class I | Active |
| Panacea | DS-HNE-UL | FDA UDI | Class I | Active |
| Bmi | HSF-RR | FDA UDI | Class I | Active |
| Panacea | DS-HNE-UR | FDA UDI | Class I | Active |
| Panacea | DS-HKO-S | FDA UDI | Class I | Active |
| Panacea | DS-KCO-PR | FDA UDI | Class I | Active |
| Bmi | HSF-PL | FDA UDI | Class I | Active |
| Bmi | AFO-X-SB | FDA UDI | Class I | Active |
| Bmi | HTA-KH-RL | FDA UDI | Class I | Active |
| Bmi | HTA-KH-LR | FDA UDI | Class I | Active |
| Bmi | AFO-RL-SB | FDA UDI | Class I | Active |
| Bmi | ECE-RR | FDA UDI | Class I | Active |
| Bmi | HSF-PR | FDA UDI | Class I | Active |
| Bmi | AFO-EL | FDA UDI | Class I | Active |
| Panacea | DS-ESO-LL | FDA UDI | Class I | Active |
| Panacea | DS-HRX-LR | FDA UDI | Class I | Active |
| Panacea | DS-HTA-PR | FDA UDI | Class I | Active |
| Panacea | DS-HRE-KH-PR | FDA UDI | Class I | Active |
| Panacea | DS-AFO-X | FDA UDI | Class I | Active |
| Bmi | MSC-PG-L | FDA UDI | Class I | Active |
| Panacea | DS-KCA-SR | FDA UDI | Class I | Active |
| Panacea | DS-HKO-R | FDA UDI | Class I | Active |
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