Identity
- Trade Name
- Lafayette Range of Motion Inclinometer FDA UDI
- Generic Name
- Electronic goniometer/kinesiology sensor FDA UDI
- Device Name
- The Lafayette Range of Motion Inclinometer is a wireless digital goniometer/inclinometer that 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. Capable of wireless communication with a second unit for dual inclinometer joint measurements. FDA UDI
- Model / Reference
- ACU100 FDA UDI
- Description
- The Lafayette Range of Motion Inclinometer is a wireless digital goniometer/inclinometer that 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. Capable of wireless communication with a second unit for dual inclinometer joint measurements. FDA UDI
Identifiers
- Catalog Number
- ACU100 FDA UDI
- Primary DI / UDI-DI
- 00855170007409 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
Lafayette Range of Motion Inclinometer by Lafayette Instrument Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Lafayette Instrument Company
Sources (1)
- FDA UDI 296b88a9-0bd4-4a7d-90ee-19b40a7a8e95 36 fields · synced May 30, 2026