Identity
- Trade Name
- sensiFirm FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system FDA UDI
- Device Name
- The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite FDA UDI
- Model / Reference
- CEL100US01SNS FDA UDI
- Description
- The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060445341118 FDA UDI
- 510(k) Number
- K170637 FDA UDI
- FDA Product Code
- GEI FDA UDIPBX FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radio-frequency skin surface treatment system
sensiFirm by El Global Trade Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin surface treatment system.
- Sterile Micro Needle Cartridge — shenb Co., Ltd. · Class II
- MiniFX — Inmode MD , Ltd. · Class II
- Venus Viva GLB package — Venus Concept Inc. · Class II
- Nutritone — Isomers Laboratories, Inc. · Class II
- POLLOGEN LEGEND — POLLOGEN LTD · Class II
- Venus Freeze kit — Venus Concept Inc. · Class II
- INFINI — Lutronic Corporation · Class II
- VIVACE Electrosurgical System — shenb Co., Ltd. · Class II
Cleared under the same submission
K170637 also covers:
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
- El Global Trade Ltd
Sources (1)
- FDA UDI 61606518-757b-481f-9b36-6ea176fe3a8a 35 fields · synced May 30, 2026