510(k) K011243
- Device
- CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
- Applicant
- Chattanooga Group, Inc.
- 510(k) number
- K011243
- Product code
- LSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-06
- Date received
- 2001-04-23
- Regulation
- 890.5100
- Classification name
- Unit, Fluidotherapy
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- CHERYL L BAGWELL
- Address
- 4717 Adams Rd. Hixson TN US 37343 37343
FDA Registration Numbers#
- 3017264244
- 9616086
Source Documents#
510(k) summary PDF not indicated by FDA