Identity
- Trade Name
- 1BYONE FDA UDI
- Generic Name
- Telemetric sphygmomanometer FDA UDI
- Device Name
- Wireless Arm Blood Pressure Monitor FDA UDI
- Model / Reference
- TMB-1585-BT FDA UDI
- Description
- Wireless Arm Blood Pressure Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858069007030 FDA UDI
- 510(k) Number
- K131395 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Telemetric sphygmomanometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Telemetric sphygmomanometer
1byone by 1byoneproducts Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Telemetric sphygmomanometer.
- Tenovi — TENOVI CO · Class II
- Tenovi — TENOVI CO · Class II
- SBPM cuff — I.E.M. GmbH · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- SBPM cuff — I.E.M. GmbH · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Cleared under the same submission
K131395 also covers:
- Easy@Home Arm Blood Pressure Monitor — EASY HEALTHCARE CORPORATION
- WowGoHealth Blood Pressure Monitor GSH885B — GOLDEN SMART HOME TECHNOLOGY CORP.
- Balance — Greater Goods, LLC
- Greater Goods — Greater Goods, LLC
- Greater Goods — Greater Goods, LLC
- Greater Goods — Greater Goods, LLC
- Greater Goods — Greater Goods, LLC
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
- 1byoneproducts Inc.
Sources (1)
- FDA UDI bdb584dd-ac80-40ce-8eab-82d6f280a683 34 fields · synced May 30, 2026