Identity
- Trade Name
- Provox Life 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
- 8210 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
- 8210 FDA UDI
- Primary DI / UDI-DI
- 07331791015175 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
MR Safe FDA UDI
Provox Life FreeHands FlexiVoice Set Plus by Atos Medical Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 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 ac21de6b-972f-4c48-9b1f-88ad37ac4ce2 38 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026