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510(k) K050295

PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES by Helio Medical Supplies, Inc. — Product Code MQX

K050295 is an FDA 510(k) premarket notification submitted by Helio Medical Supplies, Inc. for the device "PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES". The FDA issued a decision of Substantially Equivalent on March 25, 2005. The device falls under product code MQX (Needle, Acupuncture, Single Use), a Class II device regulated under 21 CFR 880.5580. Helio Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2005
Date Received
February 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Acupuncture, Single Use
Device Class
Class II
Regulation Number
880.5580
Review Panel
HO
Submission Type

Other clearances by Helio Medical Supplies, Inc.

  • K080221 — EA STIMULATOR (September 9, 2008)
  • K072778 — BRIO ACUPUNCTURE NEEDLES (November 19, 2007)
  • K062448 — LYRA ACUPUNCTURE NEEDLES (September 20, 2006)
  • K052723 — SEVEN STAR NEEDLE (January 13, 2006)
  • K043277 — C&G ACUPUNCTURE NEEDLE (February 8, 2005)
  • K024207 — VINCO BRAND ACUPUNCTURE NEEDLE (April 14, 2003)
  • K012583 — ACUGLIDE BRAND ACUPUNCTURE NEEDLES (December 11, 2001)
  • K991508 — ACUMASTER BRAND ACUPUNCTURE NEEDLE (August 27, 1999)
  • K991507 — KANGNIAN BRAND ACUPUNCTURE NEEDLE (August 27, 1999)
  • K961339 — CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES (July 3, 1996)

Other clearances for product code MQX

  • K162566 — AIK Sterile Acupuncture Needles for Single Use (May 11, 2017)
  • K142760 — Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles (August 25, 2015)
  • K150903 — EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, (July 15, 2015)
  • K142920 — KM Needles (Acupuncture Needle) (June 10, 2015)
  • K141473 — SMC ACUPUNCTURE NEEDLE (August 1, 2014)
  • K132896 — CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, (December 2, 2013)
  • K111392 — WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) (November 4, 2011)
  • K103061 — BIOMATE STERILE ACUPUNCTURE NEEDLE (June 20, 2011)
  • K092240 — ACUPUNCTURE NEEDLES (April 21, 2010)
  • K090199 — JIAJIAN ACUPUNCTURE NEEDLE (August 11, 2009)

FDA data resources