Identity
- Trade Name
- ROMI Dual Inclinometer System FDA UDI
- Generic Name
- Electronic goniometer/kinesiology sensor FDA UDI
- Device Name
- Pair of Lafayette Range of Motion Inclinometers designed for quick wireless connection when taking dual inclinometer measurements. The Lafayette Range of Motion Inclinometer is capable of taking measurements in three different planes. It can record maximal range of motion movements in flexion/extension, rotation, or front to back. An easy-to-read LCD screen displays the real-time angle along with up to six previously recorded measurements. FDA UDI
- Model / Reference
- ACU100-DUAL FDA UDI
- Description
- Pair of Lafayette Range of Motion Inclinometers designed for quick wireless connection when taking dual inclinometer measurements. The Lafayette Range of Motion Inclinometer is capable of taking measurements in three different planes. It can record maximal range of motion movements in flexion/extension, rotation, or front to back. An easy-to-read LCD screen displays the real-time angle along with up to six previously recorded measurements. FDA UDI
Identifiers
- Catalog Number
- ACU100-DUAL FDA UDI
- Primary DI / UDI-DI
- 00855170007416 FDA UDI
- FDA Product Code
- KQX FDA UDI
- GMDN Term
- Electronic goniometer/kinesiology sensor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1500 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
Yes
FDA UDI
Category: Electronic goniometer/kinesiology sensor
ROMI Dual Inclinometer System by Lafayette Instrument Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electronic goniometer/kinesiology sensor.
- myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes — FUTURE HEALTH WORKS LTD · Class I
- E-LINK N100 Small Goniometer — BIOMETRICS LIMITED · Class II
- XACT Robotics: Respiration Sensor All Around Strap — XACT ROBOTICS LTD · Class II
- MotionSense Knee Alignment Block — ENMOVI LTD · Class I
- MotionSense Knee Alignment Block — ENMOVI LTD · Class I
- Titronics — Titronics Research & Development Co. · Class I
- Digital Knee® — OPUM TECHNOLOGIES SERVICES LIMITED · Class I
- E-LINK R500 ROM Kit (Range of Motion) — BIOMETRICS LIMITED · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lafayette Instrument Company
Sources (1)
- FDA UDI 15f98a0f-6260-4e85-9b06-f82f67f3cf3e 36 fields · synced May 30, 2026