Home / 510(k) Clearances / K861864

510(k) K861864

MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT by I-Rep, Inc. — Product Code IMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1986
Date Received
May 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type

Other clearances by I-Rep, Inc.

  • K930692 — LATHAM TABLE (February 2, 1994)
  • K930691 — ACCUTRAC TRACTION UNIT (July 22, 1993)
  • K854947 — REHABILITATION TABLES (January 3, 1986)
  • K851690 — ADJUSTABLE TREATMENT TABLES (May 7, 1985)
  • K842268 — VACUPULSE VACUUM UNIT (July 20, 1984)
  • K832940 — ROTAGYM (November 7, 1983)
  • K822906 — PHYSICAL MEDICINE & REHABILITATION EQUIP (October 15, 1982)

Other clearances for product code IMJ

  • K250376 — ViVY (November 5, 2025)
  • K243112 — Curapuls 670 (June 25, 2025)
  • K223620 — Reprieve by RegenesisTM (May 24, 2023)
  • K182363 — BTL-703 (January 24, 2019)
  • K173300 — ViaTherm BOOST (May 1, 2018)
  • K162240 — ProMedTek Model C1400 Shortwave Diathermy Device (November 17, 2016)
  • K161862 — ThermoPro (November 14, 2016)
  • K153456 — Megapulse III Shortwave Diathermy (June 14, 2016)
  • K131926 — THERMOPULSE (July 24, 2014)
  • K131899 — SW-THERM (March 14, 2014)