Plinth
A Plinth is a firm, flat padded treatment table used in Physical Medicine and rehabilitation for patient examination, therapeutic exercise, massage, and manual therapy procedures, providing a stable and adjustable surface for a wide range of clinical interventions. 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 INT, regulated under 21 CFR 890.3520, 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
- INT
- Device Class
- FDA class 1
- Regulation Number
- 890.3520
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K770723 | TABLE, TREATMENT, THERAPY, PHYSICAL | Jul 11, 1977 | Substantially Equivalent | Chattanooga Pharmacal Co. |
| K770636 | TABLE, EXAM & MANUPULATION | Apr 15, 1977 | Substantially Equivalent | I E Industries |
| K770609 | TABLE, MASSAGE & TREATMHNT, FIXED HEIGHT | Apr 08, 1977 | Substantially Equivalent | Will Ross Co. |
| K770509 | TABLE, MASSAGE AND TREATMENT | Apr 05, 1977 | Substantially Equivalent | Will Ross Co. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.