Identity
- Trade Name
- Electro Flo® Percussor FDA UDI
- Generic Name
- Chest-percussion airway secretion-clearing system control unit FDA UDI
- Device Name
- The Electro Flo 5000 is an electrically powered percussor, intended to assist in airway clearance therapy when the physician’s choice of therapy is external manipulation of the thorax. Additionally, the Electro Flo 5000 is indicated for external manipulation of the thorax to promote airway clearance and improve bronchial drainage. FDA UDI
- Model / Reference
- 5000 FDA UDI
- Description
- The Electro Flo 5000 is an electrically powered percussor, intended to assist in airway clearance therapy when the physician’s choice of therapy is external manipulation of the thorax. Additionally, the Electro Flo 5000 is indicated for external manipulation of the thorax to promote airway clearance and improve bronchial drainage. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00862528000302 FDA UDI
- 510(k) Number
- K031876 FDA UDI
- FDA Product Code
- BYI FDA UDI
- GMDN Term
- Chest-percussion airway secretion-clearing system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5665 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
No
FDA UDI
Category: Chest-percussion airway secretion-clearing system applicatorChest-percussion airway secretion-clearing system control unit
Electro Flo® Percussor by Med Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Med Systems
Sources (1)
- FDA UDI 5ec53058-d5f4-47e3-894d-d962df482f61 36 fields · synced Jun 8, 2026