Reference Electrode Cable (Med4)

GUDID 04032767648825

Otto Bock Healthcare Products GmbH

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04032767648825
• NIH Device Record Key: b9fe2e41-52f1-4903-8cf4-4478abd142df
• Commercial Distribution Discontinuation: 2020-03-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Reference Electrode Cable (Med4)
• Version Model Number: 9001C03
• Company DUNS: 300802068
• Company Name: Otto Bock Healthcare Products GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04032767648825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080950

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-03-19
• Device Publish Date: 2016-09-23

Devices Manufactured by Otto Bock Healthcare Products GmbH

• 04064411004800 - Electrode: 2020-03-27
• 04064411004824 - Electrode: 2020-03-27
• 04064411004848 - Suction Socket Electrode: 2020-03-27
• 04064411004879 - Suction Socket Electrode: 2020-03-27
• 04064411005159 - Remote Electrode: 2020-03-27
• 04064411005166 - Remote Electrode: 2020-03-27
• 04064411005173 - Remote Electrode: 2020-03-27
• 04064411005180 - Remote Electrode: 2020-03-27