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510(k) K972093

REGENESIS MODEL 42 by Regenesis Biomedical, Inc. — Product Code ILX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1997
Date Received
June 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Regenesis Biomedical, Inc.

  • K223620 — Reprieve by RegenesisTM (May 24, 2023)
  • K131979 — PROVANT THERAPY SYSTEM (December 13, 2013)
  • K091791 — PROVANT SYSTEM, MODEL 4201 (April 7, 2010)

Other clearances for product code ILX

  • K241395 — Active System; Avenue8 (December 18, 2024)
  • K202337 — Pulsed electromagnetic field wrap (December 15, 2020)
  • K190251 — RecoveryRx (June 28, 2019)
  • K131979 — PROVANT THERAPY SYSTEM (December 13, 2013)
  • K121702 — ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE (May 6, 2013)
  • K121338 — ZEOBI (July 27, 2012)
  • K091791 — PROVANT SYSTEM, MODEL 4201 (April 7, 2010)
  • K092044 — ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE (December 18, 2009)
  • K091996 — ORTHOCOR KNEE SYSTEM BASIC (December 15, 2009)
  • K070541 — IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II (December 11, 2008)