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510(k) K926316

TRUE-TRAC, STRATUS by Henley Intl. — Product Code JFB

K926316 is an FDA 510(k) premarket notification submitted by Henley Intl. for the device "TRUE-TRAC, STRATUS". The FDA issued a decision of Substantially Equivalent on March 24, 1993. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Henley Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1993
Date Received
December 15, 1992
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 Henley Intl.

  • K943449 — NEUROLOGICAL DIAGNOSTIC DEVICES (November 15, 1995)
  • K926279 — UPPER BODY EXERCISER (May 5, 1994)
  • K926278 — STAIR CLIMBER (May 5, 1994)
  • K926287 — EXERCISE BICYCLE (March 22, 1994)
  • K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER (March 18, 1994)
  • K926313 — COMPUTERIZED TESTING AND EXERCISE SYSTEMS (February 4, 1994)
  • K915864 — MONOTRODE CUTANEOUS ELECTRODE (July 21, 1993)
  • K922036 — SONOPULS 591 (June 29, 1993)
  • K920983 — SONOPULS 590 (March 9, 1993)
  • K922020 — ENDOMED 582 (September 22, 1992)

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