Identity
- Trade Name
- SLENDERTONE CoreFit Abs 8 FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- The SLENDERTONE CoreFit Abs 8, Type 734 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. It is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen FDA UDI
- Model / Reference
- 734 FDA UDI
- Description
- The SLENDERTONE CoreFit Abs 8, Type 734 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. It is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen FDA UDI
Identifiers
- Catalog Number
- 0734-5000 FDA UDI
- Primary DI / UDI-DI
- 15099058734007 FDA UDI
- FDA Product Code
- NGX FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-usePhysical therapy transcutaneous neuromuscular electrical stimulation system
SLENDERTONE CoreFit Abs 8 by Bio-Medical Research, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Bio-Medical Research, Ltd.
Sources (1)
- FDA UDI 4c03a5da-5139-4528-957a-f06d20ebd49c 34 fields · synced May 31, 2026