S & W Model 29
by S & W Enterprises, Inc. 510(k)
Active
510(k) K830875
Overview
The device is a multi-function table for physical therapy, classified as a Class II medical device under regulation number 890.5880. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway.
It is manufactured by S & W Enterprises, Inc. and assigned product code JFB. The device is authorized under FDA 510(k) clearance K830875, with registration and FEI numbers listed in the openFDA data. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or clinical indications is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830875 | Date8 Apr 1983 | 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- Withdrawn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
Other devices from S & W Enterprises, Inc.
Questions
What is the S & W MODEL 29 used for?
The S & W MODEL 29 is a multi-function table designed for physical therapy applications, as indicated by its classification under regulation number 890.5880 and product code JFB for physical medicine devices.
How was the S & W MODEL 29 cleared for market?
The device was cleared via the traditional FDA 510(k) pathway under clearance number K830875, based on a determination of substantial equivalence to a predicate device.
Who manufactures the S & W MODEL 29 and where is it located?
The S & W MODEL 29 is manufactured by S & W Enterprises, Inc., located at 4221 Richmond Rd., NW, Walker, MI 49534, United States.