Identity
- Trade Name
- SensaTONE EUDAMEDFDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- The SensaTONE is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain. FDA UDI
- Model / Reference
- SensaTONE EUDAMEDD-BC06TA EUDAMEDPF-SENSATONE FDA UDI
- Description
- The SensaTONE is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060079210675 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060079210675 EUDAMED
- 510(k) Number
- K041164 FDA UDI
- FDA Product Code
- GZJ FDA UDI
- EMDN Code
- Z12062780 FUNCTIONAL ELECTRICAL STIMULATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5890 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
SensaTONE by Body Clock Health Care Limited — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060079210675 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Body Clock Health Care Limited
- EUDAMED SRN
- GB-MF-000007381
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 88f48830-0aab-49c1-9183-9ebb1dd9d310 61 fields · synced Aug 2, 2026
- FDA UDI c36ffe1f-6d3e-428f-8d4e-d9bdb4bddab9 34 fields · synced May 30, 2026