STIMEL-03 Stimulating Electrodes

GUDID 00860009465626

The device is to be solely used with the STIMEL-03 (STR-001) device.

MOTION INFORMATICS LTD

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00860009465626
• NIH Device Record Key: d9c50006-6268-44e7-b925-563f1fe6a5fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STIMEL-03 Stimulating Electrodes
• Version Model Number: STR-004
• Company DUNS: 600021218
• Company Name: MOTION INFORMATICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009465626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130424

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-04
• Device Publish Date: 2024-11-26

Devices Manufactured by MOTION INFORMATICS LTD

• 00860009465626 - STIMEL-03 Stimulating Electrodes: 2024-12-04The device is to be solely used with the STIMEL-03 (STR-001) device.
• 00860009465626 - STIMEL-03 Stimulating Electrodes: 2024-12-04 The device is to be solely used with the STIMEL-03 (STR-001) device.
• 00860009465602 - STIMEL-03: 2024-11-25