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510(k) K801593

LEBODY BY WATER PIK by Teledyne, Inc. — Product Code ISA

K801593 is an FDA 510(k) premarket notification submitted by Teledyne, Inc. for the device "LEBODY BY WATER PIK". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. Teledyne, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
July 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Therapeutic, Electric
Device Class
Class I
Regulation Number
890.5660
Review Panel
PM
Submission Type

Other clearances by Teledyne, Inc.

  • K871828 — TED MODEL 760 (February 4, 1988)
  • K863131 — PIK POCKET (IRRIGATING TIP) (August 26, 1986)
  • K862695 — FLUOR-ETCH GEL ETCHANT (July 31, 1986)
  • K854817 — INSTAPURE (February 28, 1986)
  • K840721 — PERIO PIK (April 25, 1984)
  • K810864 — WATER PIK ORAL HYGIENE CENTER (April 21, 1981)
  • K810805 — WATER PIK AUTOMATIC TOOTHBRUSH (April 14, 1981)
  • K800919 — ORAVIEW BY WATER PIK (May 8, 1980)
  • K800448 — WATER PIK TRAVELER, MODEL 79 (March 5, 1980)

Other clearances for product code ISA

  • K243488 — VMAT PRO (February 6, 2025)
  • K240358 — ShockPhysio Mobile (model SW3200 Basic) (June 5, 2024)
  • K221865 — BTL-094 (April 14, 2023)
  • K210166 — Omnispec ED1000 (January 27, 2023)
  • K213120 — OW100S (model OW100S-US) (October 12, 2022)
  • K220538 — DolorClast Radial (July 11, 2022)
  • K210451 — OrthoGold 100 (May 5, 2021)
  • K182682 — OrthoGold 100 (December 21, 2018)
  • K173692 — D-Actor 200 Vibration Massage System (April 13, 2018)
  • K053225 — CELLU M6 KEYMODULE I (November 6, 2006)

FDA data resources