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Flexitouch Plus

FDA UDI

Class II (US FDA UDI)

by Tactile Systems Technology Inc

Identity

Trade Name
Flexitouch Plus FDA UDI
Generic Name
Intermittent venous compression system pump FDA UDI
Device Name
Trunk Garment, Assembled, Small FDA UDI
Model / Reference
3A-TR-SM-B FDA UDI
Description
Trunk Garment, Assembled, Small FDA UDI

Identifiers

Primary DI / UDI-DI
00816305023923 FDA UDI
510(k) Number
K203178 FDA UDI
FDA Product Code
JOW FDA UDI
PPS FDA UDI
GMDN Term
Intermittent venous compression system pump FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5800 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

No

FDA UDI

Category: Intermittent venous compression system pump

Flexitouch Plus by Tactile Systems Technology Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intermittent venous compression system pump.

Cleared under the same submission

K203178 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tactile Systems Technology Inc

Sources (1)

  • FDA UDI c2584c6d-bc16-46eb-a17d-23ac3f423c34 34 fields · synced Jun 1, 2026