Identity
- Trade Name
- Ultimate rTMS FDA UDI
- Generic Name
- Magnetic neural stimulation system FDA UDI
- Device Name
- Stimulator FDA UDI
- Model / Reference
- M-100 Ultimate FDA UDI
- Description
- Stimulator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971538580019 FDA UDI
- 510(k) Number
- K230735 FDA UDI
- FDA Product Code
- OBP FDA UDI
- GMDN Term
- Magnetic neural stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5805 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Magnetic neural stimulation system
Ultimate rTMS by Shenzhen Yingzhi Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Magnetic neural stimulation system.
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro Accessories — Tonica Elektronik A/S · Class II
- MagPro — Tonica Elektronik A/S · Class II
- CloudTMS Edge for OCD — NEUROSOFT, OOO · Class II
Cleared under the same submission
K230735 also covers:
- Positioning Cap — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil Cooler — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil Cooler — Shenzhen Yingzhi Technology Co., Ltd.
- Trolley — Shenzhen Yingzhi Technology Co., Ltd.
- Ultimate rTMS — Shenzhen Yingzhi Technology Co., Ltd.
- Ultimate rTMS — Shenzhen Yingzhi Technology Co., Ltd.
- Ultimate rTMS — Shenzhen Yingzhi Technology Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Yingzhi Technology Co., Ltd.
Sources (1)
- FDA UDI 22b33f59-9cbf-4421-bd6c-f184c91fb2e6 35 fields · synced Jun 6, 2026