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510(k) K091791

PROVANT SYSTEM, MODEL 4201 by Regenesis Biomedical, Inc. — Product Code ILX

K091791 is an FDA 510(k) premarket notification submitted by Regenesis Biomedical, Inc. for the device "PROVANT SYSTEM, MODEL 4201". The FDA issued a decision of Substantially Equivalent on April 7, 2010. The device falls under product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Regenesis Biomedical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2010
Date Received
June 17, 2009
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)
  • 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)
  • K131979 — PROVANT THERAPY SYSTEM (December 13, 2013)
  • K121702 — ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE (May 6, 2013)
  • K121338 — ZEOBI (July 27, 2012)
  • 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)

FDA data resources