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
Model / Reference: Normatec 3/REJ6/Control Unit Basics FDA UDI

Identifiers

Primary DI / UDI-DI: 00810050282277 FDA UDI
510(k) Number: K220217 FDA UDI
FDA Product Code: IRP FDA UDI
GMDN Term: Sequential venous compression system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5650 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: 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.

Mueller Sports Medicine — Mueller Sports Medicine, Inc. · Class II
HYDROVEN — Huntleigh Healthcare , Ltd. · Class II
AeroWrap™ Flex Large — SUN-SCIENTIFIC INC. · Class I
Rapid Reboot Recovery Products — RAPID REBOOT RECOVERY PRODUCTS · Class II
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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Normatec Industries, Lp

Sources (1)

FDA UDI a70a0178-ea26-4b0e-9391-aec236d52835 33 fields · synced May 30, 2026