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510(k) K112890

NORMATEC MVP by NormaTec Industries, LP — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2012
Date Received
September 30, 2011
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

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

Other clearances for product code IRP

  • K251622 — Hand Massager (SM004D) (January 28, 2026)
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  • 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)