SCM-3 and Accessories
FDA 510(k) K914921 · Gaymar Industries, Inc.
510(k) numberK914921
Submission
- Device name
- SCM-3 and Accessories
- Applicant
- Gaymar Industries, Inc.
Orchard Park, NY, US - Received
- November 4, 1991
- Decision date
- March 12, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K813226 | Gel Flotation MattressIKY · Traditional | Jefferson Industries, Inc. | 12/02/1981SE |
| K802833 | Tetra Natal-Mat Water Flotation Mat.IKY · Traditional | Tetra Group U.S.A., Inc. | 12/10/1980SE |
| K802781 | Bedding Pads Eggcreate PadsIKY · Traditional | Leemart Bedding Mfg. Co. | 12/10/1980SE |
| K780779 | Econo-Float Water Flotation MattressIKY · Traditional | Jefferson Industries, Inc. | 05/19/1978SE |
| K772062 | Neonatal Flotation SystemIKY · Traditional | Medpro, Inc. | 11/15/1977SE |
| K771824 | Medpro Flotation SystemIKY · Traditional | Medpro, Inc. | 10/19/1977SE |
| K760963 | Decubitus MattressIKY · Traditional | Arco Medical Products Co. | 11/18/1976SE |
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| K073675 | T-Pump Localized Temperature Therapy PumpILO · Traditional | 05/08/2008SE |
| K962788 | Clinidyne Rotational Therapy Mattress SystemIKZ · Traditional | 04/30/1997SE |
| K963067 | Sof. Press Epc 51 SystemJOW · Traditional | 01/28/1997SE |
| K961854 | SPR Plus II Overlay System (CL250/CL212FNM · Traditional | 08/09/1996SE |
| K942881 | TC 3000DWJ · Traditional | 05/23/1995SE |
| K930345 | TC2000 Power Unit and AccessoriesDWJ · Traditional | 08/06/1993SE |
| K914805 | TC-1000, TC-1050 SystemDWJ · Traditional | 01/07/1992SE |
| K914851 | CLA-1400 SystemIOQ · Traditional | 11/13/1991SE |
| K912051 | Medi-Therm (MTA-5900) & Detachable HosesDWJ · Traditional | 07/30/1991SE |
Questions and answers
When was SCM-3 and Accessories cleared by the FDA?
SCM-3 and Accessories (K914921) received a 510(k) decision of Substantially Equivalent on March 12, 1992, 129 days after the submission was received.
What is the product code of K914921?
The FDA product code is IKY – Mattress, Flotation Therapy, Non-Powered, a Class I (low risk) device regulated under 21 CFR 880.5150.