Identity
- Trade Name
- Slendertone Arms FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Neuromuscular Electrical Stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance of the triceps and biceps muscles. FDA UDI
- Model / Reference
- 397 (390, X60) FDA UDI
- Description
- Neuromuscular Electrical Stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance of the triceps and biceps muscles. FDA UDI
Identifiers
- Catalog Number
- 0397-5044 FDA UDI
- Primary DI / UDI-DI
- 15099058397011 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 Arms 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 76a5f798-ae4f-4eb3-a8d7-77ef52da7655 34 fields · synced May 30, 2026