Norelco Vibrating Board V900
FDA 510(k) K830715 · North American Philips Corp.
510(k) numberK830715
Submission
- Device name
- Norelco Vibrating Board V900
- Applicant
- North American Philips Corp.
Mchenry, IL, US - Received
- March 9, 1983
- Decision date
- May 25, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IRO – Vibrator, Therapeutic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5975
- Specialty
- Physical Medicine
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More from Ultrassage, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842486 | Electronic Digital BP Meter HC 3001DXN · Traditional | 08/24/1984SE |
| K841489 | Norelco Electronic Digital BP Meter · Traditional | 04/10/1984SESP |
| K833755 | Electronic Digital Fever ThermometerFLL · Traditional | 01/30/1984SE |
| K830687 | Norelco Electronic Analog Blood PressDXN · Traditional | 05/18/1983SE |
| K830686 | Aneroid Blood Pressure Cuff #HC1400DXN · Traditional | 05/18/1983SE |
| K830685 | Norelco Deluxe Digital Blood PressureDXN · Traditional | 05/18/1983SE |
| K830684 | Norelco Electronic Digital Blood PressDXN · Traditional | 05/18/1983SE |
| K813451 | Uva Fluorescent Tanning LampsIOB · Traditional | 01/28/1982SE |
| K811891 | Norelco Massager Plus Heat BeltISA · Traditional | 07/20/1981SE |
| K811636 | Norelco Electronic Blood Pressure MeterDXN · Traditional | 06/30/1981SE |
Questions and answers
When was Norelco Vibrating Board V900 cleared by the FDA?
Norelco Vibrating Board V900 (K830715) received a 510(k) decision of Substantially Equivalent on May 25, 1983, 77 days after the submission was received.
What is the product code of K830715?
The FDA product code is IRO – Vibrator, Therapeutic, a Class I (low risk) device regulated under 21 CFR 890.5975.