Harmony SHR™ M1-00010

GUDID 00850039266096

Patient Attachments are the primary intended points of contact between the patient and Harmony SHR™. This set includes two small size Hand Attachments.

Harmonic Bionics, Inc.

Assistive dynamic arm support system

• Primary Device ID: 00850039266096
• NIH Device Record Key: bdeeb45a-30d4-4dad-b80a-9f625cee790d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony SHR™
• Version Model Number: M1-00010
• Catalog Number: M1-00010
• Company DUNS: 080508425
• Company Name: Harmonic Bionics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	00850039266096 [Primary]

FDA Product Code

• IKK: System, Isokinetic Testing And Evaluation

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: 2023-06-30
• Device Publish Date: 2023-06-22

On-Brand Devices [Harmony SHR™]

• 00850039266126: Patient Attachments are the primary intended points of contact between the patient and Harmony S
• 00850039266119: Patient Attachments are the primary intended points of contact between the patient and Harmony S
• 00850039266102: Patient Attachments are the primary intended points of contact between the patient and Harmony S
• 00850039266096: Patient Attachments are the primary intended points of contact between the patient and Harmony S
• 00850039266089: Patient Attachments are the primary intended points of contact between the patient and Harmony S
• 00850039266072: Patient Attachments are the primary intended points of contact between the patient and Harmony S
• 00850039266065: Patient Attachments are the primary intended points of contact between the patient and Harmony S
• 00850039266058: Patient Attachments are the primary intended points of contact between the patient and Harmony S
• 00850039266041: Patient Attachments are the primary intended points of contact between the patient and Harmony S
• 00850039266034: Patient Attachments are the primary intended points of contact between the patient and Harmony S
• 00850039266010: Patient Attachments are the primary intended points of contact between the patient and Harmony S
• 00850039266003: Harmony SHR™ is a bilateral upper extremity exoskeleton that works with a patient’s scapuloh