Provox FreeHands FlexiVoice Strong
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Provox FreeHands FlexiVoice Strong EUDAMEDFDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Device Name
- Provox FreeHands FlexiVoice EUDAMEDThe Provox FreeHands FlexiVoice consists of two parts assembled together, a speaking valve for single patient use and a disposable HME cassette. The speaking valve has two modes; Automatic Speaking Mode and Locked Mode. FDA UDI
- Model / Reference
- 8163 EUDAMEDFDA UDI
- Description
- The Provox FreeHands FlexiVoice consists of two parts assembled together, a speaking valve for single patient use and a disposable HME cassette. The speaking valve has two modes; Automatic Speaking Mode and Locked Mode. FDA UDI
Identifiers
- Catalog Number
- 8163 FDA UDI
- Primary DI / UDI-DI
- 07331791008313 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-HME-0-000-0007-XW EUDAMED
- 510(k) Number
- K141380 FDA UDI
- FDA Product Code
- EWL FDA UDI
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
- GMDN Term
- Tracheostomy tube speech valve FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3730 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Tracheostomy tube speech valve
Provox FreeHands FlexiVoice Strong by Atos Medical Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube speech valve.
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- InHealth Technologies; Blom-Singer® — FREUDENBERG MEDICAL, LLC · Class II
- Montgomery® Tracheostomy Speaking Valve — Boston Medical Products, Inc. · Class II
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Cleared under the same submission
K141380 also covers:
- Provox FreeHands FlexiVoice Arch (5 pcs) — ATOS MEDICAL INC.
- Provox FreeHands FlexiVoice Light — ATOS MEDICAL INC.
- Provox FreeHands FlexiVoice Medium — ATOS MEDICAL INC.
- Provox FreeHands FlexiVoice Set — ATOS MEDICAL INC.
- Provox FreeHands FlexiVoice Set Plus — ATOS MEDICAL INC.
- Provox FreeHands FlexiVoice XtraStrong — ATOS MEDICAL INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (2)
- FDA UDI cf9fda4c-c911-4982-9420-52ec95996629 37 fields · synced Jul 12, 2026
- EUDAMED 87cde805-d7d9-459c-b5e9-0ee7c3df661f 61 fields · synced Jul 12, 2026