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Sign in to claim this brandEkcomed Inc.
United States·US-MF-000048880
Last updated May 30, 2026
What Ekcomed Inc. makes
Ekcomed Inc. manufactures single-use medical devices designed for orthopedic and surgical applications, including limb/torso/head restraints and suture knot pushers. Their product line also includes specialized kits for ankle distraction, shoulder stabilization, and suspension, such as the Ankle Distraction Kit, Critter Stabilization Device, McPull Shoulder Kit, TBC Shoulder Kit, and Shoulder Suspension Sleeve Kit.
All devices produced by Ekcomed Inc. fall under Class I regulatory classification. Their products are listed in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system, reflecting compliance with applicable regulatory requirements. The company is based 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 Ekcomed Inc. manufacture?
Ekcomed Inc. specializes in single-use medical devices primarily for orthopedic and surgical procedures. Their product line includes limb/torso/head restraints and suture knot pushers, as well as specialized kits like the Ankle Distraction Kit, Critter Stabilization Device, McPull Shoulder Kit, TBC Shoulder Kit, and Shoulder Suspension Sleeve Kit. These devices are designed to assist in stabilization, distraction, and suspension during surgical interventions.
Where is Ekcomed Inc. based?
Ekcomed Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. and international standards for medical device compliance.
Which regulatory registries list Ekcomed Inc.’s devices?
Ekcomed Inc.’s devices are listed in the EU’s eudamed database and the U.S. FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with regulatory requirements, allowing healthcare providers and authorities to verify device details and authorization status.
How are Ekcomed Inc.’s devices classified under medical device regulations?
All devices manufactured by Ekcomed Inc. fall under Class I regulatory classification. This classification applies to low-risk devices that pose minimal potential harm to patients, such as single-use restraints and stabilization kits. Class I devices typically require less stringent regulatory oversight compared to higher-risk categories.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 318, Pacific Avenue, Waverly, United States
- Website
- ekcomed.com
- —
- —
- [email protected]
- Phone
- 800-517-1833
- PRRC Contact
- Richard Barrett
- EUDAMED SRN
- US-MF-000048880
- FDA FEI Number
- —
- DUNS Number
- 119213735
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ekcomed | EKM-CFMA100 | FDA UDI | Class I | Active |
| Ekcomed | EKM-SR10B | FDA UDI | Class I | Active |
| Ekcomed | EKM-PPR0634 | FDA UDI | Class I | Active |
| Ekcomed | EKM-SMFM1064 | FDA UDI | Class I | Active |
| Ekcomed | EKM-CFM10559 | FDA UDI | Class I | Active |
| Ekcomed | EKM-SAN0195 | FDA UDI | Class I | Active |
| Ekcomed | EKM-PCB00635 | FDA UDI | Class I | Active |
| Ankle Distraction Kit | EKM-AD14407 | EUDAMEDFDA UDI | Class I | Active |
| Critter Stabilization Device | EKM-CSD10573 | EUDAMEDFDA UDI | Class I | Active |
| McPull Shoulder Kit | EKM-MCP401 | EUDAMEDFDA UDI | Class I | Active |
| TBC Shoulder Kit | EKM-TBC1644 | EUDAMEDFDA UDI | Class I | Active |
| Shoulder Suspension Sleeve Kit | EKM-SSS1606 | EUDAMEDFDA UDI | Class I | Active |
| DKP Knee Kit | EKM-DKP294 | EUDAMEDFDA UDI | Class I | Active |
| Shoulder Suspension Kit | EKM-SD937 | EUDAMEDFDA UDI | Class I | Active |
| Shoulder Suspension Sleeve V Kit | EKM-SSS1606V | EUDAMEDFDA UDI | Class I | Active |
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