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Sign in to claim this brandOtto Bock Healthcare Products GmbH
US
Last updated May 24, 2026
What Otto Bock Healthcare Products GmbH makes
Otto Bock Healthcare Products GmbH manufactures myoelectric hand prostheses, including trial kits and remote electrode systems for signal detection, as well as myoelectric cuffs designed to interface with prosthetic limbs.
These devices are classified as Class II under regulatory frameworks and are listed via FDA 510(k) and FDA UDI registries. 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 Otto Bock Healthcare Products GmbH primarily manufacture?
Otto Bock Healthcare Products GmbH specializes in myoelectric hand prostheses, which are artificial limbs controlled by muscle signals. Their portfolio includes trial kits like the Myo Plus, remote electrode systems for detecting muscle activity, and myoelectric cuffs that interface with prosthetic limbs. These devices are designed to restore hand function for individuals with limb loss.
Where is Otto Bock Healthcare Products GmbH based?
The company is headquartered in the United States. While Otto Bock Healthcare Products GmbH is legally based in Germany, the specific entity referenced here operates under a U.S. regulatory framework, aligning its devices with FDA requirements.
How are Otto Bock Healthcare Products GmbH’s devices classified under regulatory standards?
Otto Bock Healthcare Products GmbH’s myoelectric hand prostheses and related components fall under Class II regulatory classification. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Which regulatory registries list Otto Bock Healthcare Products GmbH’s devices?
The company’s devices are listed in the FDA 510(k) Premarket Notification registry, which documents submissions for devices deemed substantially equivalent to legally marketed predicates. Additionally, they appear in the FDA Unique Device Identifier (UDI) System, ensuring traceability and identification of each device type through standardized codes.
Why are Otto Bock Healthcare Products GmbH’s myoelectric devices regulated under Class II?
Class II classification is assigned to devices that generally do not pose significant risk but still require validation of safety and performance. Myoelectric prostheses, while not invasive, must reliably translate muscle signals into controlled limb movement, necessitating rigorous testing and compliance with performance standards—justifications for their Class II designation.
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
- 300802068
Catalogue (89)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Electrode Accessories | 13E153 | FDA UDI | Class II | Unknown |
| Electrode | 13E200=60 | FDA UDI | Class II | Active |
| Myo Cuff | 757M20=60-OB | FDA UDI | Class II | Active |
| Myo Cuff | 757M20=60 | FDA UDI | Class II | Active |
| Remote Electrode | 13E400=G140-50-OB | FDA UDI | Class II | Unknown |
| Stiwell Med4 Support Base | 9001M07 | FDA UDI | Class II | Unknown |
| Carrying Clip for Med4 | 9001M03 | FDA UDI | Class II | Unknown |
| Electrode Accessories | 13E201 | FDA UDI | Class II | Unknown |
| case sticker | 9001L05 | FDA UDI | Class II | Unknown |
| Remote Electrode | 13E401=G90-50 | FDA UDI | Class II | Active |
| Remote Electrode | 13E401=G90-50 | FDA UDI | Class II | Unknown |
| Remote Electrode | 13E400=G140-50 | FDA UDI | Class II | Unknown |
| Myo Cuff | 757M20=50-S | FDA UDI | Class II | Unknown |
| Remote Electrode | 13E400=G90-50-OB | FDA UDI | Class II | Unknown |
| Suction Socket Electrode | 13E202=50 | FDA UDI | Class II | Active |
| Myo Cuff | 757M20=50-OB | FDA UDI | Class II | Active |
| Myo Cuff | 757M20=60-OB | FDA UDI | Class II | Unknown |
| Myo Cuff | 757M20=50 | FDA UDI | Class II | Unknown |
| Stimulation Electrode Cable (orange) | 9001C02=2.3 | FDA UDI | Class II | Unknown |
| Stimulation Electrode Cable (Yellow) | 9001C02=4 | FDA UDI | Class II | Unknown |
| Remote Electrode | 13E401=G140-50 | FDA UDI | Class II | Unknown |
| Stimulation Electrode Cable (Lilac) | 9001C02=11 | FDA UDI | Class II | Unknown |
| Electrode Accessories | 13E206 | FDA UDI | Class II | Unknown |
| Remote Electrode | 13E401=G140-60 | FDA UDI | Class II | Unknown |
| Elect-Cable w. Straight Plug & 13E121(2) | 13E129=G300 | FDA UDI | Class II | Unknown |
| Remote Electrode | 13E401=G140-50-OB | FDA UDI | Class II | Active |
| Remote Electrode | 13E400=G140-50-OB | FDA UDI | Class II | Active |
| Remote Electrode | 13E400=G140-50 | FDA UDI | Class II | Active |
| PC-Applications STIWELL med4 | 646C130=US-V1.2 | FDA UDI | Class II | Unknown |
| Remote Electrode | 13E401=G90-60-OB | FDA UDI | Class II | Active |
| Lamination Pattern | 13E191 | FDA UDI | Class II | Unknown |
| Reference Electrode Cable (Med4) | 9001C03 | FDA UDI | Class II | Unknown |
| Suction Socket Electrode | 13E202=60 | FDA UDI | Class II | Active |
| Remote Electrode | 13E401=G90-50-OB | FDA UDI | Class II | Unknown |
| Stimulation Electrode Cable (green) | 9001C02=3 | FDA UDI | Class II | Unknown |
| Cable Plug | 13E121 | FDA UDI | Class II | Unknown |
| myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | K253256 | FDA 510(k) | Class II | Active |
| Myo Plus | K191179 | FDA 510(k) | Class II | Active |
| Mygait Stimulation System | K141812 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Otto Bock Healthcare Products GmbH Vienna Wien · AT FEI 3005190268