gudid
Primary ID: VDP0016
Gymform Abs-A-Round (UDI VDP0016)
Manufactured by Well Brain International Limited
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Gymform Abs-A-Round - Primary ID VDP0016
Device Regulatory Overview
The Gymform Abs-A-Round (Model/Catalog Number: VDP0016) is a medical device manufactured by Well Brain International Limited. This product is indexed under FDA Product Code / Category Classification NGX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- VDP0016
- Product Code / EMDN
- NGX
- Device Name
- The Gymform Abs-A-Round EMS Belt is FDA Class II 510k cleared intended to apply electrical stimulation transcutaneously to tone, firm, and temporarily strengthen muscles through using the electric current pulse generator and the noninvasive electrodes. The EMS belt is a battery powered muscle stimulator, an over-the-counter device indicated for using to stimulate healthy muscles to facilitate and improve muscle performance in the intended areas on the body, a complimentary way to perform muscular training.
- Database Sync Date
- 2026-08-09 09:06:39
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Gymform Abs-A-Round?
The registered manufacturer of record for Gymform Abs-A-Round is Well Brain International Limited.
What is the Primary UDI-DI identifier for Gymform Abs-A-Round?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is VDP0016.
What classification code is assigned to this device?
This device is registered under product classification code NGX.
Similar Classification Devices (NGX)
Other Devices by Well Brain International Limited
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