Identity
- Trade Name
- Provox FreeHands FlexiVoice Set Plus FDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Device Name
- 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
- Model / Reference
- 7757 FDA 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
- 7757 FDA UDI
- Primary DI / UDI-DI
- 07331791008276 FDA UDI
- 510(k) Number
- K141380 FDA UDI
- FDA Product Code
- EWL FDA UDI
- GMDN Term
- Tracheostomy tube speech valve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3730 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
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 Set Plus 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 Light — ATOS MEDICAL INC.
- Provox FreeHands FlexiVoice Medium — ATOS MEDICAL INC.
- Provox FreeHands FlexiVoice Set — 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 ba869501-c9e0-4a59-8724-c7ca3adf469a 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026