ReGrasp

GUDID 17540176030208

EPK Pens

Rehabtronics Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 17540176030208
• NIH Device Record Key: f0375cf4-cc65-4f4a-97ee-548c5b30755c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReGrasp
• Version Model Number: EPKPN
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17540176030208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153163

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: 2024-03-04
• Device Publish Date: 2024-02-23

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