NormaTec

FDA UDI

Class II (US FDA UDI)

by Normatec Industries, Lp

Identity

Trade Name: NormaTec FDA UDI
Generic Name: Sequential venous compression system FDA UDI
Device Name: Normatec 3 Left Arm Attachment FDA UDI
Model / Reference: Normatec 3 Arm Attachment/REJ 6 FDA UDI
Description: Normatec 3 Left Arm Attachment FDA UDI

Identifiers

Primary DI / UDI-DI: 00810050281805 FDA UDI
510(k) Number: K183328 FDA UDI
K220217 FDA UDI
FDA Product Code: IRP FDA UDI
JOW FDA UDI
GMDN Term: Sequential venous compression system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5650 FDA UDI
870.5800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-chamber venous compression system garment, reusable Sequential venous compression system

NormaTec by Normatec Industries, Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sequential venous compression system.

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CoreTech — VIVE HEALTH LLC · Class II
AeroWrap™ — SUN-SCIENTIFIC INC. · Class I
Compression Therapy Device — Guangzhou Longest Medical Technology Co., Ltd. · Class II
Aero-Wrap™ Bilateral Kit, Medium — SUN-SCIENTIFIC INC. · Class I

Cleared under the same submission

K183328 also covers:

K220217 also covers:

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: Normatec Industries, Lp

Sources (1)

FDA UDI 0c7522b5-e087-4bbc-87cb-65bba299469a 34 fields · synced May 30, 2026