Econo-Float Water Flotation Mattress

FDA 510(k) K780779 · Jefferson Industries, Inc.

Substantially Equivalent

510(k) numberK780779

Submission

Device name
Econo-Float Water Flotation Mattress
Applicant
Jefferson Industries, Inc.
Walker, MI, US
Received
May 11, 1978
Decision date
May 19, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IKY – Mattress, Flotation Therapy, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 880.5150
Specialty
General Hospital

Other 510(k)s with product code IKY

510(k)DeviceApplicantDecision
K914921SCM-3 and AccessoriesIKY · Traditional Gaymar Industries, Inc.03/12/1992SE
K813226Gel Flotation MattressIKY · Traditional Jefferson Industries, Inc.12/02/1981SE
K802833Tetra Natal-Mat Water Flotation Mat.IKY · Traditional Tetra Group U.S.A., Inc.12/10/1980SE
K802781Bedding Pads Eggcreate PadsIKY · Traditional Leemart Bedding Mfg. Co.12/10/1980SE
K772062Neonatal Flotation SystemIKY · Traditional Medpro, Inc.11/15/1977SE
K771824Medpro Flotation SystemIKY · Traditional Medpro, Inc.10/19/1977SE
K760963Decubitus MattressIKY · Traditional Arco Medical Products Co.11/18/1976SE

More from Arco Medical Products Co.

510(k)DeviceDecision
K813225Gel Flotation CushionKIC · Traditional 12/03/1981SE
K813226Gel Flotation MattressIKY · Traditional 12/02/1981SE
K802603Econo-Float Wheelchair Flotation CushionKID · Traditional 11/12/1980SE

Questions and answers

When was Econo-Float Water Flotation Mattress cleared by the FDA?

Econo-Float Water Flotation Mattress (K780779) received a 510(k) decision of Substantially Equivalent on May 19, 1978, 8 days after the submission was received.

What is the product code of K780779?

The FDA product code is IKY – Mattress, Flotation Therapy, Non-Powered, a Class I (low risk) device regulated under 21 CFR 880.5150.