FDA 510(k) · Cadwell Laboratories
K040986: CADWELL LIMB MOVEMENT MODULE (Cadwell Laboratories, Inc.)
Cadwell Laboratories, Inc. received FDA 510(k) K040986 for CADWELL LIMB MOVEMENT MODULE, with a decision date of Jul 1, 2004 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K040986 |
|---|---|
| Pathway | 510(k) |
| Applicant | Cadwell Laboratories, Inc. |
| Device name | CADWELL LIMB MOVEMENT MODULE |
| Product code | LEL: Device, Sleep Assessment |
| Regulation (21 CFR) | 882.5050 |
| Device class | Class 2 |
| Date received | Apr 15, 2004 |
| Decision date | Jul 1, 2004 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
510(k) Number: K040986 Device Name: Cadwell Limb Movement Module Indications for use: The Cadwell EasyNet Limb Movement Module is intended for use to detect periodic limb movements for recording onto a physiological recorder. It may be used in a clinical or ambulatory setting for both EEG and sleep disorder studies. Contraindications: No absolute contraindications Precautions: This product is for diagnostic purposes only and is not to be used in a life supporting or life-sustaining situation. Warnings: The EasyNet Limb Movement Module is NOT sealed against the ingress of fluids. Do not bathe while wearing the module. Do not use if wet. Not for use in the presence of explosive atmosphere or flammable anesthetics Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, Page 1of 1 and Neurological Devices 510(k) Number. A'/½'?C&k
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code LEL is "Device, Sleep Assessment", class 2, 21 CFR 882.5050.
Our labels for filtering: claim Sleep, sensor Other. These are heuristics, not FDA fields.