acculove

GUDID 00818218029047

The product is suitable to be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.

Famidoc Technology Co.,Ltd.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00818218029047
• NIH Device Record Key: 96961cc0-41d5-46ec-9767-e68c0d8d1127
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: acculove
• Version Model Number: FDEP108
• Company DUNS: 421343701
• Company Name: Famidoc Technology Co.,Ltd.
• 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	00818218029047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130723

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-08-02
• Device Publish Date: 2019-04-25

On-Brand Devices [acculove]

• 00854314007237: FDES108
• 00854314007220: FDES116
• 00854314007190: FDIR-V4
• 00854314007183: The product is suitable to be used for temporary relief of pain associated with sore and aching
• 00854314007206: FDES116
• 00818218024813: FDES108
• 00818218024806: FDES116
• 00818218024790: FDES116
• 00818218021058: FDIR-V4
• 00818218029047: The product is suitable to be used for temporary relief of pain associated with sore and aching