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firefly
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref SK1RW02Model K-1Ref ST2RW02Model T-2
Identity
- Trade Name
- firefly EUDAMEDFDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Knee Strap EUDAMEDFDA UDINeuromuscular Electro-Stimulation Device EUDAMED
- Model / Reference
- K-1 EUDAMEDFDA UDISK1RW02 EUDAMEDT-2 EUDAMEDST2RW02 EUDAMED
- Description
- Knee Strap FDA UDI
Identifiers
- Catalog Number
- SK1RW02 FDA UDI
- Primary DI / UDI-DI
- 05060294770107 EUDAMEDFDA UDI05060294771746 EUDAMED
- Basic UDI-DI
- 506029477K1PL EUDAMED506029477T2QH EUDAMED
- 510(k) Number
- K134001 FDA UDI
- FDA Product Code
- IPF FDA UDI
- EMDN Code
- V0499 CLINICAL USE CONTAINERS (NON-IVD) - OTHER EUDAMEDN0199 ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - OTHER EUDAMED
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5850 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument transport trolley system
firefly by Firstkind Limited — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201131 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K134001 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 506029477K1PL | Class I | Active |
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Manufacturer
- Manufacturer
- Firstkind Limited
- EUDAMED SRN
- GB-MF-000010541
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED a1a0a74d-1097-4bc6-b67c-d74febb429bb 61 fields · synced Sep 18, 2026
- EUDAMED 6d72bf38-554e-4937-a0e1-159c5f5a5b08 61 fields · synced May 18, 2026
- FDA UDI 20b433cd-0b95-4c5a-8ab0-f161973de51b 35 fields · synced May 30, 2026
- FDA 510(k) K201131 1 fields · synced May 18, 2026