Epulse

GUDID 06971712720033

Mini Massager ULTRA 1420

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712720033
• NIH Device Record Key: 6401ae44-aa68-4ace-bf1c-331c19a13f2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epulse
• Version Model Number: Epulse Ultra 1420
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 36
• DM Exempt: true
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971712720033 [Primary]
GS1	06971712720040 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201354
• Premarket Notification: K233092

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2024-11-04
• Device Publish Date: 2019-12-14

On-Brand Devices [Epulse]

• 06971712720040: TENS
• 06971712720026: TENS
• 06971712725304: SM9079
• 06971712720033: Mini Massager ULTRA 1420
• 06971712727520: SM9187