Nu Skin RenuSpa iO

GUDID 00850021097554

NSE PRODUCTS, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00850021097554
• NIH Device Record Key: ae783f2e-0d71-4be7-a61a-90619972ea71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nu Skin RenuSpa iO
• Version Model Number: BS2RM
• Company DUNS: 803486393
• Company Name: NSE PRODUCTS, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00850021097554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232001

FDA Product Code

• NFO: Stimulator, transcutaneous electrical, aesthetic purposes

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: 2023-12-05
• Device Publish Date: 2023-11-27

Devices Manufactured by NSE PRODUCTS, INC.

• 00850021097554 - Nu Skin RenuSpa iO: 2023-12-05
• 00850021097554 - Nu Skin RenuSpa iO: 2023-12-05
• 00850021097561 - Nu Skin RenuSpa iO Package: 2023-12-05
• 00850021097578 - AP 24® Smile Pop Toothbrush: 2023-08-21
• 00860196000303 - Nu Skin Facial Spa: 2019-10-23
• 00860196000327 - Nu Skin Facial Spa Package: 2019-10-23
• 00860196000310 - Nu Skin Conductive Gel: 2018-07-06