acculove

GUDID 00818218024813

Famidoc Technology Co.,Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00818218024813
• NIH Device Record Key: 342a63fa-f14d-4892-861d-3c2d692468b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: acculove
• Version Model Number: FDES108
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818218024813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113010

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-07-19
• 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