510(k) K011768
- Device
- THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
- Applicant
- Thermo-Electric Co.
- 510(k) number
- K011768
- Product code
- LSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-03
- Date received
- 2001-06-07
- Regulation
- 890.5100
- Classification name
- Unit, Fluidotherapy
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- LAWRENCE E MADSON
- Address
- 455 Rt. 30 Imperial PA US 15126 15126
FDA Registration Numbers#
- 3017264244
- 9616086