Identity
- Trade Name
- POWER PLAY FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Device Name
- POWERPLAY PUMP FDA UDI
- Model / Reference
- PPRT01 FDA UDI
- Description
- POWERPLAY PUMP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04042809585773 FDA UDI
- 510(k) Number
- K122154 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Sequential venous compression system inflator 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sequential venous compression system inflator
Power Play by Compression Solutions, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sequential venous compression system inflator.
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- Bio Compression Systems Sequential Circulator Model SC-3008-IS — BIO COMPRESSION SYSTEMS, INC. · Class II
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Cleared under the same submission
K122154 also covers:
- POWER PLAY — Compression Solutions, LLC
- POWER PLAY — Compression Solutions, LLC
- POWER PLAY — Compression Solutions, LLC
- POWER PLAY — Compression Solutions, LLC
- POWER PLAY — Compression Solutions, LLC
- POWER PLAY — Compression Solutions, LLC
- POWER PLAY — Compression Solutions, LLC
- POWER PLAY — Compression Solutions, LLC
- POWER PLAY — Compression Solutions, LLC
- POWER PLAY — Compression Solutions, LLC
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
- Compression Solutions, LLC
Sources (1)
- FDA UDI d89f1b72-09ad-4c18-a93e-3dd82029376e 35 fields · synced May 30, 2026