Replexa+ Device

GUDID 00850886008009

Replexa+ Model C1416 Shortwave Diathermy Device

PROMEDTEK, INC.

Short-wave diathermy treatment system, home-use

• Primary Device ID: 00850886008009
• NIH Device Record Key: 5ad6fd6d-4b2f-44c1-be4a-8b9e6409dda5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Replexa+ Device
• Version Model Number: C1416
• Company DUNS: 604679527
• Company Name: PROMEDTEK, 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: true
• 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

Customer Support Contacts

• Phone: 8663882410
• Email: info@promedtek.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850886008009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162240

FDA Product Code

• IMJ: Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

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: 2019-07-16
• Device Publish Date: 2019-07-08

Devices Manufactured by PROMEDTEK, INC.

• 00850886008009 - Replexa+ Device: 2019-07-16Replexa+ Model C1416 Shortwave Diathermy Device
• 00850886008009 - Replexa+ Device: 2019-07-16 Replexa+ Model C1416 Shortwave Diathermy Device
• 00850886008016 - Replexa+ Treatment Applicator: 2019-07-16 Replexa+ Model C1416 Shortwave Diathermy Treatment Applicator