Electrical Vibrating Device
FDA 510(k) K821133 · Durham Electric Co.
510(k) numberK821133
Submission
- Device name
- Electrical Vibrating Device
- Applicant
- Durham Electric Co.
Mchenry, IL, US - Received
- April 20, 1982
- Decision date
- July 9, 1982
- 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
Other 510(k)s with product code IRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955250 | Qi Gong MassagerIRO · Traditional | East Health Development Group, Inc. | 02/08/1996SN |
| K955160 | Comfort, Muscle, Cordless Massager, Battery Powered Operated MassagerIRO · Traditional | Everapex Design & Marketing Corp. | 02/08/1996SN |
| K954203 | Massager Theraputic, ElectricIRO · Traditional | Cisco Sales Corp. | 12/11/1995SN |
| K952916 | Shiatsu Master Massager CushionIRO · Traditional | Kinsei Shiatsu, Inc. | 08/28/1995SN |
| K951414 | Champion Physioacousticc Recliner-Transporter ChairIRO · Traditional | Champion Mfg. Corp. | 08/11/1995SN |
| K950441 | Conair Family Fitness Body EnergyIRO · Traditional | Conair Corp. | 07/18/1995SE |
| K946382 | Skalpi 3200IRO · Traditional | Wiscco Development, Inc. | 05/30/1995SE |
| K950410 | Conair Body and SoleIRO · Traditional | Conair Corp. | 05/23/1995SE |
| K944909 | Wahl Fresh FaceIRO · Traditional | Wahl Clipper Corp. | 05/08/1995SE |
| K950400 | Hand Massage UnitIRO · Traditional | Ultrassage, Inc. | 03/30/1995SE |
Questions and answers
When was Electrical Vibrating Device cleared by the FDA?
Electrical Vibrating Device (K821133) received a 510(k) decision of Substantially Equivalent on July 9, 1982, 80 days after the submission was received.
What is the product code of K821133?
The FDA product code is IRO – Vibrator, Therapeutic, a Class I (low risk) device regulated under 21 CFR 890.5975.