Identity
- Trade Name
- E-LINK Hand Kit FDA UDI
- Generic Name
- Hand dynamometer/pinchmeter, electronic FDA UDI
- Device Name
- The E-LINK Hand Kit which includes a Dynamometer and Pinchmeter for monitoring grip and pinch strength, is the ideal module to quantify and monitor the effectiveness of various interventions for the upper extremity, throughout the whole rehabilitation process. The Hand Kit can also be used with the E-LINK Activities (Games), for innovative isometric grip and pinch exercises that are totally focused on the individual patient. The Hand Kit (H500) is available with either a wireless or wired interface FDA UDI
- Model / Reference
- H500 FDA UDI
- Description
- The E-LINK Hand Kit which includes a Dynamometer and Pinchmeter for monitoring grip and pinch strength, is the ideal module to quantify and monitor the effectiveness of various interventions for the upper extremity, throughout the whole rehabilitation process. The Hand Kit can also be used with the E-LINK Activities (Games), for innovative isometric grip and pinch exercises that are totally focused on the individual patient. The Hand Kit (H500) is available with either a wireless or wired interface FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481690041 FDA UDI
- FDA Product Code
- ISD FDA UDI
- GMDN Term
- Hand dynamometer/pinchmeter, electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5360 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
No
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
Category: Hand dynamometer/pinchmeter, electronic
E-LINK Hand Kit by Biometrics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand dynamometer/pinchmeter, electronic.
- microfet handgrip — Hoggan Scientific L.L.C. · Class II
- JAMAR — Asp Global, LLC · Class I
- Echo Grip Gauge — J-Tech Medical, Inc. · Class I
- DualGrip Digital Grip Dynamometer — Lafayette Instrument Company · Class I
- microFET Pinch — Hoggan Scientific L.L.C. · Class II
- Eforto — Uniweb · Class II
- Northstar Echo Grip Gauge — J-Tech Medical, Inc. · Class I
- SR-3053 — RED OAK INSTRUMENTS, LLC · 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
- Biometrics Limited
Sources (1)
- FDA UDI 41a3ea93-db4d-4032-b9e0-83e322190fd2 33 fields · synced May 30, 2026