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510(k) K042596

LSA HELIUM by Lifestand — Product Code IPL

K042596 is an FDA 510(k) premarket notification submitted by Lifestand for the device "LSA HELIUM". The FDA issued a decision of Substantially Equivalent on January 26, 2005. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Lifestand has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2005
Date Received
September 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Standup
Device Class
Class II
Regulation Number
890.3900
Review Panel
PM
Submission Type

Other clearances by Lifestand

  • K061726 — LSC, MODEL 3 (December 4, 2006)
  • K041535 — LSC LIFESTAND COMPACT (September 16, 2004)

Other clearances for product code IPL

  • K243783 — Walking rehabilitation training electric wheelchair (ZW518) (March 12, 2025)
  • K202728 — Action Trackchair Hawk (February 10, 2022)
  • K203761 — ParaMotion (January 21, 2022)
  • K191334 — Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04 (May 29, 2020)
  • K190682 — Explorer Mini (February 27, 2020)
  • K191874 — F5 Corpus VS (October 25, 2019)
  • K182257 — UPnRIDE (September 12, 2019)
  • K191376 — Modular Power Standing System (August 13, 2019)
  • K172384 — Quickie(r) Q700-UP M (January 16, 2018)
  • K163451 — Action Trackstander models TR1816, TR1820, TR2016, and TR2020 (January 12, 2018)

FDA data resources