Identity
- Trade Name
- PF Kit EUDAMEDNice Stretch FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- NICE STRETCH® PF Kit EUDAMEDPlantar Fasciitis Kit FDA UDI
- Model / Reference
- 53105 EUDAMEDFDA UDILarge/X-Large EUDAMED
- Description
- Plantar Fasciitis Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821615310502 EUDAMED00082161531050 FDA UDI
- Basic UDI-DI
- 081261NSPFKLGXLNN EUDAMED
- FDA Product Code
- FYH FDA UDI
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
- GMDN Term
- Ankle/foot orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3910 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ankle/foot orthosis
Nice Stretch by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
Sources (2)
- FDA UDI 30d70f2a-e92c-43f2-b7b2-d4de106dc2e3 33 fields · synced Jul 15, 2026
- EUDAMED e9b74aea-7ff5-45e1-8442-798703618e5d 61 fields · synced Jul 15, 2026