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510(k) K131979

PROVANT THERAPY SYSTEM by Regenesis Biomedical, Inc. — Product Code ILX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2013
Date Received
June 28, 2013
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)
  • K091791 — PROVANT SYSTEM, MODEL 4201 (April 7, 2010)
  • K972093 — REGENESIS MODEL 42 (October 21, 1997)

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)
  • 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)
  • K070931 — MODEL PMT850 (May 24, 2007)