Identity
- Trade Name
- NormaTec FDA UDI
- Generic Name
- Sequential venous compression system FDA UDI
- Device Name
- The Normatec Go is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. FDA UDI
- Model / Reference
- Normatec Go/ ALJ7/ Calf Wrap FDA UDI
- Description
- The Normatec Go is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810050283793 FDA UDI
- 510(k) Number
- K221666 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
No
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.
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- 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
K221666 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 0836528f-33bd-4a97-98b2-753b7f106ab8 34 fields · synced May 30, 2026