AccelStim 4300

GUDID 08050040997213

Bone Growth Stimulator

IGEA SPA

Bone growth ultrasonic stimulator

• Primary Device ID: 08050040997213
• NIH Device Record Key: 9ab88acd-270e-4f91-9b44-0f20fcf0c81f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccelStim
• Version Model Number: UBHS-02
• Catalog Number: 4300
• Company DUNS: 429342710
• Company Name: IGEA SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	08050040997213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210035

FDA Product Code

• LOF: Stimulator, Bone Growth, Non-Invasive

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: 2022-07-22
• Device Publish Date: 2022-07-14

On-Brand Devices [AccelStim]

• 08050040997213: Bone Growth Stimulator
• 08050040997329: Replacement Power Supply, Accelstim 4300
• 08050040997312: Replacement Transducer Holder, Accelstim 4300
• 08050040997305: Replacement Strap, Accelstim 4300
• 08050040997299: Replacement Ultrasound Gel, Accelstim 4300
• 08050040997336: Replacement Aquasonics 100 Ultrasound Gel, AccelStim 4300