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510(k) K203847

Reprocessed Tri Pulse Compression Garment by Renu Medical, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2021
Date Received
December 31, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

Other clearances by Renu Medical, Inc.

  • K121145 — RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL (June 12, 2012)
  • K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE (November 16, 2011)
  • K093658 — RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS (January 14, 2010)
  • K081927 — RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO (February 6, 2009)
  • K072194 — RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 (November 29, 2007)
  • K063661 — RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 (May 25, 2007)
  • K051227 — RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 (April 7, 2006)
  • K031559 — RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES (November 12, 2003)

Other clearances for product code JOW

  • K254267 — NanoPress 760A-BT (760A-BT) (February 24, 2026)
  • K250974 — Bio Arterial Deluxe (IC-BAP-DX) (December 12, 2025)
  • K250190 — Sequential Compression System (SCD600) (December 8, 2025)
  • K251466 — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compressio (October 28, 2025)
  • K251446 — PlasmaFlow X Compression Sleeve Device (XPF0001) (September 17, 2025)
  • K251086 — PnueAira (PNCU-01) (August 18, 2025)
  • K250817 — Coretech Compression System (Coretech RHB3003) (August 8, 2025)
  • K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (January 15, 2025)
  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
  • K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRES (October 4, 2024)