Acu-Massage Table
by H.W.E., Inc. 510(k)
Active
510(k) K822693
Overview
The Acu-Massage Table is a multi-function physical therapy table designed for medical use. It incorporates motorized mechanisms to deliver heat, traction, and muscle relaxation therapy, supporting physical medicine interventions.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as physical therapy clinics or rehabilitation centers. It operates with preset cycles, including a 15-minute massage function with an audible buzzer alert upon completion. The device holds an FDA 510(k) clearance under the product code JFB, classified as a Class II medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822693 | Date21 Sep 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JFB
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5880
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent