Identity
- Trade Name
- SP-2000 FDA UDI
- Generic Name
- Intermittent venous compression system FDA UDI
- Device Name
- Main device 1ea, LEG SLEEVE XLarge 2ea, Double Hose 1ea [One set box] FDA UDI
- Model / Reference
- SP20200-BX FDA UDI
- Description
- Main device 1ea, LEG SLEEVE XLarge 2ea, Double Hose 1ea [One set box] FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315672269 FDA UDI
- 510(k) Number
- K202395 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Intermittent 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intermittent venous compression system
Sp-2000 by Daesung Maref Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intermittent venous compression system.
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- Pulse Carry Case — NORMATEC INDUSTRIES, LP · Class II
- Rapid Reboot Recovery Products — RAPID REBOOT RECOVERY PRODUCTS · Class II
- Pulse Boot — NORMATEC INDUSTRIES, LP · Class II
Cleared under the same submission
K202395 also covers:
- 4 chamber extension zipper — DAESUNG MAREF CO., LTD.
- 4 chamber extension zipper — DAESUNG MAREF CO., LTD.
- 4 chamber extension zipper — DAESUNG MAREF CO., LTD.
- 4 chamber extension zipper — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- Hose — DAESUNG MAREF CO., LTD.
- Hose — DAESUNG MAREF CO., LTD.
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
- Daesung Maref Co., Ltd.
Sources (1)
- FDA UDI dd955bcc-ac02-4081-9619-58d136e5a9f8 34 fields · synced Jun 1, 2026