Who is the manufacturer of CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000?

Chattanooga Group, Inc. submitted the Traditional clearance for CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 (K011243).

What is the FDA product code for CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000?

LSB. It is classified under 21 CFR 890.5100 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000?

510(k) clearance (submission type: Traditional).

CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000

K011243 · Chattanooga Group, Inc. · LSB · Jul 6, 2001 · Physical Medicine

Device Facts

Record ID	K011243
Device Name	CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
Applicant	Chattanooga Group, Inc.
Product Code	LSB · Physical Medicine
Decision Date	Jul 6, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5100
Device Class	Class 2

Regulatory Classification

Identification

An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.