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geko
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref DT2EN01Model T-2Ref W3FE01-07Model W-3 packRef T3EA02Model T-3Ref T3RWP2Ref W3RW01Model W-3Ref W3RW01-07Ref T3RW02510(k) K160299Ref T3BG02
Identity
- Trade Name
- geko EUDAMED
- Device Name
- Neuromodulation Device EUDAMEDNeuromuscular Stimulation Device Pack EUDAMEDNeuromuscular Electro-stimulation Device EUDAMED
- Model / Reference
- T-2 EUDAMEDDT2EN01 EUDAMEDW-3 pack EUDAMEDW3FE01-07 EUDAMEDT-3 EUDAMEDT3EA02 EUDAMEDT3RWP2 EUDAMEDW-3 EUDAMEDW3RW01 EUDAMEDW3RW01-07 EUDAMEDT3RW02 EUDAMEDT3BG02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060294772170 EUDAMED05060294772118 EUDAMED05060294771555 EUDAMED05060294771258 EUDAMED05060294771975 EUDAMED05060294771517 EUDAMED05060294772095 EUDAMED05060294770954 EUDAMED05060294771296 EUDAMED05060294771524 EUDAMED
- Basic UDI-DI
- 506029477T2PTNSBQ EUDAMED506029477W3pkEZ EUDAMED506029477T3QK EUDAMED506029477W3QU EUDAMED
- 510(k) Number
- K160299 FDA 510(k)
- FDA Product Code
- IPF FDA 510(k)
- EMDN Code
- N0199 ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- Medical Purpose
- • to increase blood circulation • for the treatment of oedema • for promoting wound healing • for the treatment of venous insufficiency and ischemia EUDAMED
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
geko by Firstkind Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K133638 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K160299 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 506029477T2PTNSBQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Firstkind Limited
- EUDAMED SRN
- GB-MF-000010541
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (13)
- EUDAMED 29d8121c-5145-4abe-b48d-2ad1161fa33b 61 fields · synced Sep 17, 2026
- EUDAMED 794b18bb-1259-4c1c-9a94-c293519bd99b 61 fields · synced May 17, 2026
- EUDAMED deaba181-f1d3-4ec9-b902-ae7fa61098b7 61 fields · synced May 17, 2026
- EUDAMED 784adad2-9c05-4aae-868e-16524a8f3a47 61 fields · synced May 17, 2026
- EUDAMED d6e6066f-f20c-4c05-a908-ef256e2280b4 61 fields · synced May 18, 2026
- EUDAMED b9774780-26f7-4f9c-989c-11aec700e156 61 fields · synced May 18, 2026
- EUDAMED aa7bfe6b-af05-44c8-bd07-3fde838bb78b 61 fields · synced May 18, 2026
- EUDAMED e2440674-cb5a-47a8-ab6e-8ddcbf34d0d1 61 fields · synced May 18, 2026
- FDA 510(k) K160299 24 fields · synced May 18, 2026
- EUDAMED 651128b3-2997-4d6a-952a-01ff473982ef 61 fields · synced Jul 9, 2026
- EUDAMED 886c58b7-091d-4efb-b5e5-9c8f33946428 61 fields · synced Jul 12, 2026
- EUDAMED ec3bd6ee-5b4a-4f65-8c9b-145548d9e034 61 fields · synced Jul 19, 2026
- EUDAMED b06e99a0-e386-4046-86ca-49a10d7108b2 61 fields · synced Sep 17, 2026