Treadmill, Mechanical
A Mechanical Treadmill is a non-powered walking device used in Physical Medicine rehabilitation that relies on the user's own movement to drive the belt, providing a surface for ambulation training, gait rehabilitation, and cardiovascular exercise without requiring electrical power. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IOG, regulated under 21 CFR 890.5370, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
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Basic Information
- Product Code
- IOG
- Device Class
- FDA class 1
- Regulation Number
- 890.5370
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920526 | STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500 | Sep 21, 1992 | Substantially Equivalent | Stryker Medical |
| K801250 | HYDRA TRED DC | Jun 17, 1980 | Substantially Equivalent | Medichanics, Inc. |
| K800251 | MT-10, ET-20 | Apr 02, 1980 | Substantially Equivalent | Associated Mills, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.