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510(k) K955160

COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER by Everapex Design & Marketing Corp. — Product Code IRO

K955160 is an FDA 510(k) premarket notification submitted by Everapex Design & Marketing Corp. for the device "COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER". The FDA issued a decision of SN on February 8, 1996. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975.

Clearance Details

Decision
SN ()
Decision Date
February 8, 1996
Date Received
November 13, 1995
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 for product code IRO

  • K955250 — QI GONG 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)
  • K945603 — CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) (February 9, 1995)

FDA data resources