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ReWalK P6.0
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ReWalk P6.0 Personal Exoskelaton Model ReWalk P6.0
Identity
- Trade Name
- ReWalK P6.0 EUDAMEDReWalk(TM) Personal 6.0 FDA UDI
- Generic Name
- Programmable ambulation exoskeleton, home-use FDA UDI
- Device Name
- ReWalk P6.0 Personal Exoskeleton EUDAMEDPowered Exoskeleton - community use FDA UDI
- Model / Reference
- ReWalk P6.0 EUDAMEDReWalk P6.0 Personal Exoskelaton EUDAMED50-20-0004 FDA UDI
- Description
- Powered Exoskeleton - community use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861803000303 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00861803000303 EUDAMED
- 510(k) Number
- K160987 FDA UDI
- FDA Product Code
- PHL FDA UDI
- EMDN Code
- Z129099 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER EUDAMED
- GMDN Term
- Programmable ambulation exoskeleton, home-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3480 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Fixture/appliance dental drill bit, reusable
ReWalK P6.0 by Lifeward Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00861803000303 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Lifeward LTD.
- EUDAMED SRN
- IL-MF-000033442
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 044972d7-b909-456f-9934-397a7d40f4a0 61 fields · synced Jul 12, 2026
- FDA UDI cc6f7ee4-9809-4341-a609-56584c6bebab 35 fields · synced May 30, 2026