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510(k) K830875

S & W MODEL 29 by S & W Enterprises, Inc. — Product Code JFB

K830875 is an FDA 510(k) premarket notification submitted by S & W Enterprises, Inc. for the device "S & W MODEL 29". The FDA issued a decision of Substantially Equivalent on April 8, 1983. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. S & W Enterprises, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1983
Date Received
March 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Physical Therapy, Multi Function
Device Class
Class II
Regulation Number
890.5880
Review Panel
PM
Submission Type

Other clearances by S & W Enterprises, Inc.

  • K864817 — S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS (January 5, 1987)
  • K841145 — TILT TABLE 53 (April 13, 1984)
  • K832768 — S & W SW52E W/POWER BACK LIFT (September 20, 1983)
  • K830873 — S & W MODEL ASO (May 13, 1983)
  • K830874 — S & W MODEL SW 37 (April 8, 1983)

Other clearances for product code JFB

  • K250266 — Ceragem Automatic Thermal Massager (CGM MB-2401) (July 11, 2025)
  • K241193 — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (January 31, 2025)
  • K243644 — Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) (January 8, 2025)
  • K243355 — Ceragem Automatic Thermal Massager (CGM-MB-1902) (November 27, 2024)
  • K240168 — N7-S (September 12, 2024)
  • K220572 — Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 (June 17, 2022)
  • K202937 — Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 (March 18, 2021)
  • K202113 — Ceragem Automatic Thermal Massager, Model CGM-MB-1901 (March 2, 2021)
  • K153054 — N5-1 (February 5, 2016)
  • K140592 — CERAGEM AUTOMATIC THERMAL MASSAGER (December 17, 2014)

FDA data resources