Question 1

What types of medical devices does Otto Bock Healthcare Products GmbH primarily manufacture?

Accepted Answer

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.

Question 2

Where is Otto Bock Healthcare Products GmbH based?

Accepted Answer

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.

Question 3

How are Otto Bock Healthcare Products GmbH’s devices classified under regulatory standards?

Accepted Answer

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.

Question 4

Which regulatory registries list Otto Bock Healthcare Products GmbH’s devices?

Accepted Answer

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.

Question 5

Why are Otto Bock Healthcare Products GmbH’s myoelectric devices regulated under Class II?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Electrode	13E200=60	FDA UDI	Class II	Unknown
Lamination Pattern for Outer Socket	13E204	FDA UDI	Class II	Unknown
Elect-Cable w. Straight Plug & 13E121(2)	13E129=G600	FDA UDI	Class II	Unknown
Myo Plus trial kit	642V64=T-PLUS-S	FDA UDI	Class II	Active
Remote Electrode	13E400=G90-50	FDA UDI	Class II	Active
Remote Electrode	13E401=G90-60	FDA UDI	Class II	Unknown
Electrode Cable with Straight Plug(2)	13E48=G600	FDA UDI	Class II	Unknown
Main Cable/Plug Med4	9001C01	FDA UDI	Class II	Unknown
Lamination Pattern for Inner Socket	13E203	FDA UDI	Class II	Unknown
Case for Med4 kit	642V16	FDA UDI	Class II	Unknown
Power Cable US version for Med4	9001C04=US	FDA UDI	Class II	Unknown
Remote Electrode	13E400=G90-60-OB	FDA UDI	Class II	Unknown
Elect- Cable wi. Straight Plug & 13E121	13E129=G100	FDA UDI	Class II	Unknown
Remote Electrode	13E400=G90-60	FDA UDI	Class II	Active
Remote Electrode	13E400=G90-60	FDA UDI	Class II	Active
Remote Electrode	13E400=G140-60-OB	FDA UDI	Class II	Unknown
Suction Socket Electrode	13E202=60	FDA UDI	Class II	Unknown
Remote Electrode	13E401=G140-60	FDA UDI	Class II	Active
Remote Electrode	13E401=G90-60	FDA UDI	Class II	Active
Myo Cuff	757M20=50-S	FDA UDI	Class II	Active
Electrode Cable with Straight Plug	13E48=G800	FDA UDI	Class II	Unknown
Silicon part	13E221	FDA UDI	Class II	Unknown
Remote Electrode	13E400=G90-60-OB	FDA UDI	Class II	Active
Remote Electrode	13E400=G140-60	FDA UDI	Class II	Unknown
Remote Electrode	13E400=G140-60-OB	FDA UDI	Class II	Active
Electrode Cable with Straight Plug	13E48=G300	FDA UDI	Class II	Unknown
Myo Plus trial kit	642V64=T-PLUS-S	FDA UDI	Class II	Unknown
Myo Cuff	757M20=50	FDA UDI	Class II	Active
Remote Electrode	13E401=G140-60-OB	FDA UDI	Class II	Unknown
Remote Electrode	13E401=G140-50-OB	FDA UDI	Class II	Unknown
Lamination pattern for outer socket	13E192	FDA UDI	Class II	Unknown
Remote Electrode	13E400=G90-50-OB	FDA UDI	Class II	Active
Myo Cuff	757M20=60	FDA UDI	Class II	Unknown
Remote Electrode	13E401=G140-50	FDA UDI	Class II	Active
External Trigger	9001M01	FDA UDI	Class II	Unknown
Myo Plus trial kit	642V64=T-PLUS-OB	FDA UDI	Class II	Active
Remote Electrode	13E400=G90-50	FDA UDI	Class II	Active
Myo Plus trial kit	642V64=T-PLUS-OB	FDA UDI	Class II	Unknown
Charger for Med4	9001P01	FDA UDI	Class II	Unknown
Remote Electrode	13E401=G90-50-OB	FDA UDI	Class II	Active
Electrode	13E200=50	FDA UDI	Class II	Active
Myo Cuff	757M20=50-OB	FDA UDI	Class II	Unknown
Remote Electrode	13E401=G140-60-OB	FDA UDI	Class II	Active
Remote Electrode	13E400=G140-60	FDA UDI	Class II	Active
Remote Electrode	13E401=G90-60-OB	FDA UDI	Class II	Unknown
Electrode	13E200=50	FDA UDI	Class II	Unknown
Elect- Cable wi. Straight Plug & 13E121	13E129=G1000	FDA UDI	Class II	Unknown
Suction Socket Electrode	13E202=50	FDA UDI	Class II	Unknown
USB Cable for Med4	9001C05	FDA UDI	Class II	Unknown
Electrode Bracket Set	13E135	FDA UDI	Class II	Unknown

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