Whirlpool Bath Model 2273
by Dazey Products Co. 510(k)
Active
510(k) K771968
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771968 | Date28 Oct 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- ILJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5100
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a bath, hydro-massage, as defined in the device specifications. It is classified under regulation number 890.5100 and product code ILJ, with a medical specialty designation in Physical Medicine.
The device received FDA 510(k) clearance as substantially equivalent on October 28, 1977, under traditional review. It is a class II medical device manufactured by Dazey Products Co., with no indication of sterility, single-use status, MRI safety, or specific size variants provided in the data.
Other devices from Dazey Products Co.
Questions
AI-generated answers, 1 Oct 2026
What is the WHIRLPOOL BATH MODEL 2273 used for?
The WHIRLPOOL BATH MODEL 2273 is a hydro-massage bath designed for therapeutic use in physical medicine, providing water-based massage to support patient treatment as part of clinical care routines.
Is the WHIRLPOOL BATH MODEL 2273 sterile or single-use?
The device data does not indicate that the WHIRLPOOL BATH MODEL 2273 is sterile or intended for single-use; it is a reusable bath system designed for repeated clinical use in physical medicine environments.
What regulatory clearance does the WHIRLPOOL BATH MODEL 2273 have?
The WHIRLPOOL BATH MODEL 2273 received FDA 510(k) clearance on October 28, 1977, under traditional review, as substantially equivalent to a predicate device, and is classified as a class II medical device under product code ILJ.