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510(k) K945603

CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) by Headwaters, Inc. — Product Code IRO

K945603 is an FDA 510(k) premarket notification submitted by Headwaters, Inc. for the device "CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)". The FDA issued a decision of SN on February 9, 1995. 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 9, 1995
Date Received
November 15, 1994
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

  • K955160 — COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER (February 8, 1996)
  • 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)

FDA data resources