PainPod

GUDID 00810093080793

PainPod Ultra Receivers (black and red)

Hi-Dow International Incorporated

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00810093080793
• NIH Device Record Key: 56e7e70d-b614-4603-b191-ee70a5b0c3d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PainPod
• Version Model Number: HD-5N-23A
• Company DUNS: 124034476
• Company Name: Hi-Dow International Incorporated
• 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: false
• Serial Number: true
• 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	00810093080793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163393

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2025-12-17
• Device Publish Date: 2025-12-09

On-Brand Devices [PainPod ]

• 00799439774025: PainPod III
• 00799439774018: PainPod XPV
• 09351609000023: PainPod Mi
• 00851640007511: Electronic Muscle Stimulator white
• 00810093080014: TENS for pain relief
• 00810093080793: PainPod Ultra Receivers (black and red)
• 00810093080786: PainPod Ultra Device ,controller PainPod Ultra Receivers (black and red)