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Vivally

FDA UDI

Class II (US FDA UDI)

by Avation Medical, Inc.

Identity

Trade Name
Vivally FDA UDI
Generic Name
Transcutaneous incontinence-control electrical stimulator FDA UDI
Model / Reference
VCG-KTM01 FDA UDI

Identifiers

Primary DI / UDI-DI
00860009634015 FDA UDI
510(k) Number
K220454 FDA UDI
FDA Product Code
NAM FDA UDI
GMDN Term
Transcutaneous incontinence-control electrical stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5310 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Transcutaneous incontinence-control electrical stimulator

Vivally by Avation Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous incontinence-control electrical stimulator.

Cleared under the same submission

K220454 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avation Medical, Inc.

Sources (1)

  • FDA UDI 7dbead1d-d455-4614-9281-1e0da9281d2b 33 fields · synced Jun 8, 2026