Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
The Upper Extremity Prosthesis with Multiple Simultaneous Degrees of Freedom and Controlled via Cutaneous Electromyography is a myoelectric prosthetic device designed to replace partially or fully amputated or congenitally absent upper extremities, providing multiple and simultaneous degrees of freedom and functionality using surface EMG control. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is PAE, with regulation number 890.3450 under the Physical Medicine medical specialty.
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Basic Information
- Product Code
- PAE
- Device Class
- FDA class 2
- Regulation Number
- 890.3450
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
Definition
Upper extremity prosthesis intended to replace partially or fully amputated or congenitally absent upper extremities and to provide multiple and simultaneous degrees of freedom and functionality.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN120016 | DEKA ARM SYSTEM | May 09, 2014 | Unknown | Deka Integrated Solutions Corporation |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.