Identity
- Trade Name
- PAL650 Pressure feeler 650g FDA UDI
- Generic Name
- External manual massager, clinical FDA UDI
- Device Name
- The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin areas of the auricular pinna by the application of variable pressure. FDA UDI
- Model / Reference
- PAL650 FDA UDI
- Description
- The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin areas of the auricular pinna by the application of variable pressure. FDA UDI
Identifiers
- Catalog Number
- 103611 FDA UDI
- Primary DI / UDI-DI
- 03760262492933 FDA UDI
- FDA Product Code
- KNM FDA UDI
- GMDN Term
- External manual massager, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5765 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: External manual massager, clinical
PAL650 Pressure feeler 650g by Sedatelec — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Sedatelec
Sources (1)
- FDA UDI 31688214-2ce8-469d-9111-27fac2e208af 35 fields · synced Jun 8, 2026