Identity
- Trade Name
- Hyperice / NormaTec FDA UDI
- Generic Name
- Hot/cold therapy system FDA UDI
- Device Name
- HYPERICE X2 KNEE FDA UDI
- Model / Reference
- HX20001 FDA UDI
- Description
- HYPERICE X2 KNEE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810050288026 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Hot/cold therapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Hot/cold therapy system
Hyperice / NormaTec by Normatec Industries, Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- NormaTec — NORMATEC INDUSTRIES, LP · Class II
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 064ce28d-a431-4860-b6c5-d35ab2a8dd25 33 fields · synced May 30, 2026