510(k) K896817
- Device
- MODEL T11 FLUIDOTHERAPY UNIT
- Applicant
- HENLEY INTL.
- 510(k) number
- K896817
- Product code
- LSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-01-18
- Date received
- 1989-12-04
- Regulation
- 890.5100
- Classification name
- Unit, Fluidotherapy
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- J HENLEY,PHD
- Address
- 104 Industrial Blvd., Sugar Land TX US 77470 77470
FDA Registration Numbers#
- 3017264244
- 9616086
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011768 | THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 | Thermo-Electric Co. | 2001-08-03 |
| K011243 | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | Chattanooga Group, Inc. | 2001-07-06 |
| K871802 | MODEL K210 AND K211 FLUIDOTHERAPY UNITS | Henley Intl. | 1987-09-04 |
Legacy Summary#
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FDA Review#
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