Unit, Fluidotherapy
The Fluidotherapy Unit is a physical therapy device that delivers dry heat treatment by suspending a body part in a fluidized bed of finely divided cellulose particles circulated by warm air, used to treat musculoskeletal conditions, improve joint mobility, and reduce pain. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LSB, regulated under 21 CFR 890.5100, within the Physical Medicine specialty. No special flags apply to this device.
Basic Information
- Product Code
- LSB
- Device Class
- FDA class 2
- Regulation Number
- 890.5100
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K011768 | THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 | Aug 03, 2001 | Substantially Equivalent | THERMO-ELECTRIC CO. |
| K011243 | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | Jul 06, 2001 | Substantially Equivalent | CHATTANOOGA GROUP, INC. |
| K896817 | MODEL T11 FLUIDOTHERAPY UNIT | Jan 18, 1991 | Substantially Equivalent | HENLEY INTL. |
| K871802 | MODEL K210 AND K211 FLUIDOTHERAPY UNITS | Sep 04, 1987 | Substantially Equivalent | HENLEY INTL. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.