Identity
- Trade Name
- SOZO Body Fluid Analyzer FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- SOZO Body Fluid Analyzer working in conjunction with SOZOapp 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 dry electrode, and displaying the results on a monitor. (Repackaged for use in Clinical evaluations (Trials)) FDA UDI
- Model / Reference
- 2826995 FDA UDI
- Description
- SOZO Body Fluid Analyzer working in conjunction with SOZOapp 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 dry electrode, and displaying the results on a monitor. (Repackaged for use in Clinical evaluations (Trials)) FDA UDI
Identifiers
- Catalog Number
- 2826995 FDA UDI
- Primary DI / UDI-DI
- B27728269950 FDA UDI
- 510(k) Number
- K172122 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
SOZO Body Fluid Analyzer by Impedimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
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 6f1b62e1-91ae-4c92-bea5-4c6d61a818cf 37 fields · synced May 30, 2026