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510(k) K080221

EA STIMULATOR by Helio Medical Supplies, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2008
Date Received
January 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Helio Medical Supplies, Inc.

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  • K052723 — SEVEN STAR NEEDLE (January 13, 2006)
  • K050295 — PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES (March 25, 2005)
  • 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)

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