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510(k) K912659

SOUND RELIEF by Windmere Corp. — Product Code IRO

K912659 is an FDA 510(k) premarket notification submitted by Windmere Corp. for the device "SOUND RELIEF". The FDA issued a decision of Substantially Equivalent on September 6, 1991. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Windmere Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1991
Date Received
June 17, 1991
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 Windmere Corp.

  • K980769 — WINDMERE MODEL DS-2 FOOT BATH (March 27, 1998)
  • K932904 — WINDMERE WAND MASSAGER (February 17, 1994)
  • K933974 — WINDMERE MASSAGE MATE (February 2, 1994)
  • K924237 — WINDMERE PRELUDE III (October 18, 1993)
  • K931086 — WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER (September 30, 1993)
  • K896245 — PLAK TRAC POWERED TOOTHBRUSH (March 28, 1990)

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