Product Code: INT FDA class 1 21 CFR 890.3520

Plinth

Physical Medicine

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.

510(k)s
4
FEI Numbers
9
Registration Numbers
9
Unique Applicants
3
Years Active
0

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number Device Name
K770723 TABLE, TREATMENT, THERAPY, PHYSICAL
K770636 TABLE, EXAM & MANUPULATION
K770609 TABLE, MASSAGE & TREATMHNT, FIXED HEIGHT
K770509 TABLE, MASSAGE AND TREATMENT

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.