Identity
- Trade Name
- Provox FreeHands FlexiVoice Light 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
- 8161 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
- 8161 FDA UDI
- Primary DI / UDI-DI
- 07331791008290 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tracheostomy tube speech valve
Provox FreeHands FlexiVoice Light 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.
- Provox Life BasePlate Adaptor — Atos Medical AB · Class I
- Nonventilatory nebulizer(atomizer)(JR-CA007-02) — Xiamen Junrong Medical Equipment Co., Ltd. · Class I
- nonventilatory nebulizer(atomizer)(JR-CA007-03) — Xiamen Junrong Medical Equipment Co., Ltd. · Class I
- InHealth Technologies; Blom-Singer® — FREUDENBERG MEDICAL, LLC · Class II
- Montgomery® Tracheostomy Speaking Valve — Boston Medical Products, Inc. · Class II
- Connector — VADI Medical Technology Co., Ltd. · Class IIb
- Humidification Chamber, Infant — BESMED HEALTH BUSINESS CORP. · Class IIa
- Patient Interfaces（Nasal Cannula） — Shenzhen Lifotronic Technology Co., Ltd. · Class IIa
Cleared under the same submission
K141380 also covers:
- Provox FreeHands FlexiVoice Arch (5 pcs) — 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 Strong — ATOS MEDICAL INC.
- Provox FreeHands FlexiVoice XtraStrong — ATOS MEDICAL INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (2)
- FDA UDI 03758056-bc1b-4a93-a9e2-cdbd5dce34ce 37 fields · synced Jul 11, 2026
- EUDAMED 039faa79-70cf-4a3c-a68f-7f92c129d840 61 fields · synced Jul 11, 2026