Identity
- Trade Name
- AffloVest FDA UDI
- Generic Name
- Chest-percussion airway secretion-clearing system FDA UDI
- Device Name
- DEMO AffloVest Small Vest FDA UDI
- Model / Reference
- DS8100 FDA UDI
- Description
- DEMO AffloVest Small Vest FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816305024432 FDA UDI
- 510(k) Number
- K122480 FDA UDI
- FDA Product Code
- BYI FDA UDI
- GMDN Term
- Chest-percussion airway secretion-clearing system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5665 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
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
Category: Chest-percussion airway secretion-clearing system
AffloVest by Tactile Systems Technology Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- FREQUENCER — Dymedso, Inc. · Class II
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tactile Systems Technology Inc
Sources (1)
- FDA UDI d22211e0-6e2c-4b84-85f3-a75ced37518d 34 fields · synced Jun 8, 2026