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Quake

FDA UDI

Class II (US FDA UDI)

by Thayer Medical Corporation

Identity

Trade Name
QUAKE FDA UDI
Generic Name
Positive pressure airway secretion-clearing device FDA UDI
Device Name
QUAKE VIBRATORY PEP DEVICE FDA UDI
Model / Reference
1297 FDA UDI
Description
QUAKE VIBRATORY PEP DEVICE FDA UDI

Identifiers

Catalog Number
1297 FDA UDI
Primary DI / UDI-DI
00383480000068 FDA UDI
510(k) Number
K974849 FDA UDI
FDA Product Code
BYI FDA UDI
GMDN Term
Positive pressure airway secretion-clearing device 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Positive pressure airway secretion-clearing device

Quake by Thayer Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Positive pressure airway secretion-clearing device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thayer Medical Corporation

Sources (1)

  • FDA UDI 5834dc95-4c27-4d63-a6aa-e417024a29e6 36 fields · synced May 30, 2026