Home / 510(k) Clearances / K946382

510(k) K946382

SKALPI 3200 by Wiscco Development, Inc. — Product Code IRO

K946382 is an FDA 510(k) premarket notification submitted by Wiscco Development, Inc. for the device "SKALPI 3200". The FDA issued a decision of Substantially Equivalent on May 30, 1995. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1995
Date Received
December 14, 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

  • 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)
  • 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