Identity
- Trade Name
- Bio Compression Systems Cryo Insert Knee - Black FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Model / Reference
- CI-3045-K/B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812311020192 FDA UDI
- 510(k) Number
- K961425 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Inflatable hot/cold therapy pack/electric pump 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Inflatable hot/cold therapy pack/electric pump
Bio Compression Systems Cryo Insert Knee - Black by Bio Compression Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Inflatable hot/cold therapy pack/electric pump.
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Cleared under the same submission
K961425 also covers:
- Bio Compression Systems 4 Chamber Cryo Ankle - Black — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems 4 Chamber Cryo Arm w/Shoulder - Large Black — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems 4 Chamber Cryo Back - Black — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems 4 Chamber Cryo Elbow Cylinder - Black — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems 4 Chamber Cryo Hand/Wrist - Black — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems 4 Chamber Cryo Knee Cylinder - Black — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems 4 Chamber Cryo Leg Extra Large - Black — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems 4 Chamber Cryo Leg Half — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems 4 Chamber Cryo Leg Large — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems 4 Chamber Cryo Leg Large - Black — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems 4 Chamber Cryo Leg Medium — BIO COMPRESSION SYSTEMS, INC.
- Bio Compression Systems 4 Chamber Cryo Leg Medium - Black — BIO COMPRESSION SYSTEMS, INC.
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
- Bio Compression Systems, Inc.
Sources (1)
- FDA UDI 7d22c41d-baca-4e5c-8336-9ca741633668 33 fields · synced Jun 1, 2026