Identity
- Trade Name
- HiTop 4touch FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Four-Channel Physical therapy transcutaneous neuromuscular electrical stimulation FDA UDI
- Model / Reference
- 027-0-0020-US FDA UDI
- Description
- Four-Channel Physical therapy transcutaneous neuromuscular electrical stimulation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260364812053 FDA UDI
- FDA Product Code
- GZJ FDA UDILIH FDA UDIIPF FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 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
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
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
HiTop 4touch by gbo Medizintechnik AG — 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
- gbo Medizintechnik AG
Sources (1)
- FDA UDI cc54b4e2-a71c-4863-984b-b5cd5303b0cd 33 fields · synced May 31, 2026