Capenergy

GUDID 08437021499049

CAPENERGY MEDICAL SL

Medium-wave diathermy treatment system

• Primary Device ID: 08437021499049
• NIH Device Record Key: 524bf8fe-fe0b-4a66-ae5b-4cae6b965a62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capenergy
• Version Model Number: C300
• Company DUNS: 463708995
• Company Name: CAPENERGY MEDICAL SL
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437021499049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191202

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced 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: 2021-02-23
• Device Publish Date: 2021-02-15

On-Brand Devices [Capenergy]

• 08437021499056: C400
• 08437021499049: C300
• 08437021499032: C200
• 08437021499025: C100
• 08437021499018: C50