ReGrasp

GUDID 17540176030123

ReGrasp Electrode Positioning Kit

Rehabtronics Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 17540176030123
• NIH Device Record Key: 27b8b4b2-75f7-4f74-9755-a58582cb16b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReGrasp
• Version Model Number: HSEPK1
• Company DUNS: 243936569
• Company Name: Rehabtronics Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17540176030123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153163

FDA Product Code

• GZI: Stimulator, Neuromuscular, External Functional

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: 2020-03-04
• Device Publish Date: 2020-02-25

On-Brand Devices [ReGrasp]

• 17540176030109: ReGrasp Replacement Wrist-Support
• 17540176030093: ReGrasp Clinician System Refill
• 17540176030086: ReGrasp Clinician System
• 17540176030079: ReGrasp Electrode Set
• 17540176030062: ReGrasp Replacement Garment (Large Size)
• 17540176030055: ReGrasp Replacement Garment (Medium Size)
• 17540176030048: ReGrasp Replacement Garment (Small Size)
• 17540176030000: ReGrasp Personal System
• 17540176030116: ReGrasp Base System
• 17540176030130: ReGrasp Electrode Positioning Kit Refill
• 17540176030123: ReGrasp Electrode Positioning Kit
• 17540176030253: EPKV2 Dock Assembly
• 17540176030246: EPK Cotton Electrodes (Small)
• 17540176030239: EPK Cotton Electrodes (Large)
• 17540176030222: EPK Small Gel Electrodes
• 17540176030215: EPK Large Gel Electrodes
• 17540176030208: EPK Pens
• 17540176030192: EPK Transfer Sheet
• 17540176030185: ReGrasp Garment Liners (large)
• 17540176030178: ReGrasp Garment Liners (medium)
• 17540176030161: ReGrasp Garment Liners (small)
• 17540176030154: ReGrasp HMS Button Control
• 17540176030147: ReGrasp Electrode Positioning Kit Version 2