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510(k) K920487

MINI VIBRATOR by Alimed, Inc. — Product Code IRO

K920487 is an FDA 510(k) premarket notification submitted by Alimed, Inc. for the device "MINI VIBRATOR". The FDA issued a decision of Substantially Equivalent on February 18, 1992. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Alimed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1992
Date Received
January 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vibrator, Therapeutic
Device Class
Class I
Regulation Number
890.5975
Review Panel
PM
Submission Type

Other clearances by Alimed, Inc.

  • K963527 — UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS (October 31, 1996)
  • K963528 — ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STR (October 29, 1996)
  • K963526 — STRAP WEDGE (October 28, 1996)
  • K840156 — PROTECTA COAT SPONGES (March 23, 1984)
  • K822650 — SUPER DONUT (September 30, 1982)
  • K822651 — TOTAL FINGER FLEXION SPLINT (September 17, 1982)
  • K820516 — ARTERIAL CANALIZATION DEVICE (April 15, 1982)
  • K820517 — CONSTRUCTA FOAM (March 10, 1982)
  • K801743 — PLASTAZOTE SHOE (August 7, 1980)
  • K791189 — ECHO CARDIOGRAM PAD (July 17, 1979)

Other clearances for product code IRO

  • K955250 — QI GONG MASSAGER (February 8, 1996)
  • K955160 — COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER (February 8, 1996)
  • K954203 — MASSAGER THERAPUTIC, ELECTRIC (December 11, 1995)
  • K952916 — SHIATSU MASTER MASSAGER CUSHION (August 28, 1995)
  • K951414 — CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR (August 11, 1995)
  • K950441 — CONAIR FAMILY FITNESS BODY ENERGY (July 18, 1995)
  • K946382 — SKALPI 3200 (May 30, 1995)
  • K950410 — CONAIR BODY AND SOLE (May 23, 1995)
  • K944909 — WAHL FRESH FACE (May 8, 1995)
  • K950400 — HAND MASSAGE UNIT (March 30, 1995)

FDA data resources