Mti Wolff System, Tanning Bed

FDA 510(k) K881492 · Health Systems Intl., Inc.

Substantially Equivalent

510(k) numberK881492

Submission

Device name
Mti Wolff System, Tanning Bed
Applicant
Health Systems Intl., Inc.
Gurnee, IL, US
Received
April 8, 1988
Decision date
April 19, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LEJ – Booth, Sun Tan
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4635
Specialty
General, Plastic Surgery

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More from Lpi, Inc.

510(k)DeviceDecision
K874232Muscle Stim. Devices, BM 2000,4000,6000,8000IPF · Traditional 03/10/1989SE
K881353Mti Wolff SystemLEJ · Traditional 04/06/1988SE
K862372Ultratan Tanning SystemFTC · Traditional 07/09/1986SE

Questions and answers

When was Mti Wolff System, Tanning Bed cleared by the FDA?

Mti Wolff System, Tanning Bed (K881492) received a 510(k) decision of Substantially Equivalent on April 19, 1988, 11 days after the submission was received.

What is the product code of K881492?

The FDA product code is LEJ – Booth, Sun Tan, a Class II (moderate risk) device regulated under 21 CFR 878.4635.