Identity
- Trade Name
- Provox ActiValve Strong 4.5 mm FDA UDI
- Generic Name
- Tracheoesophageal speech valve, indwelling FDA UDI
- Device Name
- The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces. FDA UDI
- Model / Reference
- 7160 FDA UDI
- Description
- The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces. FDA UDI
Identifiers
- Catalog Number
- 7160 FDA UDI
- Primary DI / UDI-DI
- 07331791000577 FDA UDI
- 510(k) Number
- K092593 FDA UDI
- FDA Product Code
- EWL FDA UDI
- GMDN Term
- Tracheoesophageal speech valve, indwelling 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
Yes
FDA UDI
Implantable
Yes
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 Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 4.5 Millimeter FDA UDI
Category: Tracheoesophageal speech valve, indwelling
Provox ActiValve Strong 4.5 mm by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tracheoesophageal speech valve, indwelling.
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Cleared under the same submission
K092593 also covers:
- Provox ActiValve Light 10 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 12.5 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 4.5 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 6 mm — ATOS MEDICAL INC.
- Provox ActiValve Light 8 mm — ATOS MEDICAL INC.
- Provox ActiValve Lubricant — ATOS MEDICAL INC.
- Provox ActiValve Strong 10 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 12.5 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 6 mm — ATOS MEDICAL INC.
- Provox ActiValve Strong 8 mm — ATOS MEDICAL INC.
- Provox ActiValve XtraStrong 10 mm — ATOS MEDICAL INC.
- Provox ActiValve XtraStrong 12.5 mm — ATOS MEDICAL INC.
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
- Atos Medical Inc.
Sources (1)
- FDA UDI 71c69b22-fa47-458b-857e-3fdd714d2981 38 fields · synced Jun 8, 2026