Identity
- Trade Name
- AffloVest FDA UDI
- Generic Name
- Chest-oscillation airway secretion-clearing system FDA UDI
- Device Name
- The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motors organized into zones. The vest may be run on battery or A/C power from a standard wall outlet. The AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician’s choice of treatment. FDA UDI
- Model / Reference
- 8300 FDA UDI
- Description
- The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motors organized into zones. The vest may be run on battery or A/C power from a standard wall outlet. The AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician’s choice of treatment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814321020063 FDA UDI
- 510(k) Number
- K122480 FDA UDI
- FDA Product Code
- BYI FDA UDI
- GMDN Term
- Chest-oscillation airway secretion-clearing system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5665 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AffloVest by Movair, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K122480 also covers:
- AffloVest — TACTILE SYSTEMS TECHNOLOGY INC
- AffloVest — TACTILE SYSTEMS TECHNOLOGY INC
- AffloVest — TACTILE SYSTEMS TECHNOLOGY INC
- AffloVest — TACTILE SYSTEMS TECHNOLOGY INC
- AffloVest — TACTILE SYSTEMS TECHNOLOGY INC
- AffloVest — TACTILE SYSTEMS TECHNOLOGY INC
- AffloVest — TACTILE SYSTEMS TECHNOLOGY INC
- AffloVest — TACTILE SYSTEMS TECHNOLOGY INC
- AffloVest — TACTILE SYSTEMS TECHNOLOGY INC
- AffloVest — TACTILE SYSTEMS TECHNOLOGY INC
- AffloVest — TACTILE SYSTEMS TECHNOLOGY INC
- AffloVest — TACTILE SYSTEMS TECHNOLOGY 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
- Movair, Inc.
Sources (1)
- FDA UDI 0fb1e83d-bdbe-4e01-85c1-b95c45818c11 35 fields · synced May 30, 2026