Sandbox I, Sandbox II, Sandbox Jr.
FDA 510(k) K903321 · Sandbox Ent.
510(k) numberK903321
Submission
- Device name
- Sandbox I, Sandbox II, Sandbox Jr.
- Applicant
- Sandbox Ent.
Mt. Gilead, OH, US - Received
- July 25, 1990
- Decision date
- February 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IRT – Pad, Heating, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5740
- Specialty
- Physical Medicine
Other 510(k)s with product code IRT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250047 | bite away twoIRT · Traditional | mibeTec GmbH | 09/12/2025SE |
| K220514 | bite away neoIRT · Traditional | mibeTec GmbH | 06/23/2022SE |
| K160943 | Bite AwayIRT · Traditional | Riemser Pharma | 08/26/2016SE |
| K142228 | Heated Eye PadIRT · Traditional | Digital Heat Corporation | 02/09/2015SE |
| K133981 | Avacen 100IRT · Abbreviated | Avacen, Inc. | 08/15/2014SE |
| K111273 | Fir Heat Theraphy SysyemsIRT · Traditional | Shenzhen Anpan Technology Co., Ltd. | 11/08/2011SE |
| K072534 | Bio-Mat 2000IRT · Traditional | Richway Intl., Inc. | 02/08/2008SE |
| K963887 | Pt-Pac Portable Heating PadIRT · Traditional | Anthony A. Chiurco | 03/31/1997SE |
| K963824 | Li's Itch StopperIRT · Traditional | Hontech Foundation For Medical Technology | 12/12/1996SE |
| K962195 | Health O Meter Electric Heating Pads Models EHP2, EHP3IRT · Traditional | Sunbeam Health Division | 11/27/1996SE |
Questions and answers
When was Sandbox I, Sandbox II, Sandbox Jr. cleared by the FDA?
Sandbox I, Sandbox II, Sandbox Jr. (K903321) received a 510(k) decision of Substantially Equivalent on February 19, 1991, 209 days after the submission was received.
What is the product code of K903321?
The FDA product code is IRT – Pad, Heating, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5740.