Identity
- Trade Name
- High Voltage Galvanic Stimulator Kit FDA UDI
- Generic Name
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
- Device Name
- CS6101-K01 Generic CS6101 Series Stimulator Kit: Contains Stimulator, lead set, one (1) set of electrodes, and AC adapter. Custom cut foam-lined carrying case and Instruction manual. FDA UDI
- Model / Reference
- CS6101-K01 Generic CS6101 Series Stimulator Kit FDA UDI
- Description
- CS6101-K01 Generic CS6101 Series Stimulator Kit: Contains Stimulator, lead set, one (1) set of electrodes, and AC adapter. Custom cut foam-lined carrying case and Instruction manual. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009424746 FDA UDI
- FDA Product Code
- LIH FDA UDIQPL FDA UDI
- GMDN Term
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Physical therapy ultrasound/neuromuscular stimulation system
High Voltage Galvanic Stimulator Kit by Control Solutions, Inc. — 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
- Control Solutions, Inc.
Sources (1)
- FDA UDI 9cd936a8-628a-485e-8537-79d950c18245 33 fields · synced May 30, 2026