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510(k) K924314

MOBILE STANDING FRAME by Metatech Corp. — Product Code IPL

K924314 is an FDA 510(k) premarket notification submitted by Metatech Corp. for the device "MOBILE STANDING FRAME". The FDA issued a decision of Substantially Equivalent on February 12, 1993. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Metatech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
August 26, 1992
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 Metatech Corp.

  • K915370 — COPPER VAPOR LASER SYSTEM (February 7, 1992)
  • K903883 — VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES (September 19, 1990)
  • K890865 — HEXASCAN SCANNER HANDPIECE (March 24, 1989)
  • K883541 — METALASER VASCULASE (November 4, 1988)
  • K883881 — MODIFIED MODEL 2001 FIBER OPTICS CATHETER (October 27, 1988)
  • K883518 — EVENT MARKER & A SECOND PRESSURE TREND OUTPUT (September 22, 1988)
  • K882552 — METATECH ROBINSON BOLT ACCESSORY (September 8, 1988)
  • K882367 — METATECH MICROCLIP APPLICATOR (August 25, 1988)
  • K882286 — EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET (July 18, 1988)
  • K881447 — METATECH METAL MICROCLIP (June 22, 1988)

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