Identity
- Trade Name
- L-Dex® U400 FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. New-Device FDA UDI
- Model / Reference
- U400 FDA UDI
- Description
- BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. New-Device FDA UDI
Identifiers
- Catalog Number
- 222-LDEXU400 FDA UDI
- Primary DI / UDI-DI
- B277222LDEXU4000 FDA UDI
- 510(k) Number
- K130338 FDA UDI
- FDA Product Code
- OBH FDA UDI
- GMDN Term
- Bioelectrical body composition analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2770 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bioelectrical body composition analyser
L-Dex® U400 by Impedimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bioelectrical body composition analyser.
- TANITA Body Composition Analyzer — Tanita Corp. · Class II
- Beurer — BEURER NORTH AMERICA, L.P. · Class II
- CONAIR — CONAIR LLC. · Class II
- RENPHO Body Composition Scale — JOICOM CORPORATION · Class II
- Etekcity — ETEKCITY CORPORATION · Class II
- truME — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. · Class II
- CONAIR — CONAIR LLC. · Class II
- TANITA/Ironman Body Composition Analyzer — Tanita Corp. · Class II
Cleared under the same submission
K130338 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 |
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Manufacturer
- Manufacturer
- Impedimed, Inc.
Sources (1)
- FDA UDI 1ffab1e6-d760-48ab-8a36-8eef35c56ee9 36 fields · synced Jun 8, 2026