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510(k) K240122

Normatec Elite by NormaTec Industries, LP — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2024
Date Received
January 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type

Other clearances by NormaTec Industries, LP

  • K251905 — Normatec Elite Hip (September 18, 2025)
  • K221666 — Normatec Go (July 14, 2022)
  • K220217 — Normatec 3 (February 25, 2022)
  • K183169 — Pulse 2.0, Pulse Pro 2.0 (December 27, 2018)
  • K183328 — Pulse Rx 2.0, Pulse Pro Rx 2.0 (December 21, 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 IRP

  • K251622 — Hand Massager (SM004D) (January 28, 2026)
  • K251662 — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505) (November 13, 2025)
  • K251531 — AIR COMPRESSION BOOTS 1018195,1018196 (October 30, 2025)
  • K253150 — Cryon-X Cold Compression (October 24, 2025)
  • K251905 — Normatec Elite Hip (September 18, 2025)
  • K251623 — Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) (September 17, 2025)
  • K250244 — Compression Therapy Device (LGT-2210DS) (July 25, 2025)
  • K242615 — Intermittent pressure compression system (Compression Pump PT1005A; Leg Compress (July 23, 2025)
  • K242754 — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (May 5, 2025)
  • K250046 — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM6 (April 25, 2025)