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510(k) K183328

Pulse Rx 2.0, Pulse Pro Rx 2.0 by NormaTec Industries, LP — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2018
Date Received
November 30, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by NormaTec Industries, LP

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  • K183169 — Pulse 2.0, Pulse Pro 2.0 (December 27, 2018)
  • K161346 — NormaTec PCD-T and PCD-B (June 15, 2016)
  • K160608 — NormaTec Pulse and NormaTec Pulse Pro (April 13, 2016)
  • K112890 — NORMATEC MVP (January 4, 2012)

Other clearances for product code JOW

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  • 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)