Sound Relief
FDA 510(k) K912659 · Windmere Corp.
510(k) numberK912659
Submission
- Device name
- Sound Relief
- Applicant
- Windmere Corp.
Miami Lakes, FL, US - Received
- June 17, 1991
- Decision date
- September 6, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
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|---|---|---|---|
| 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 |
More from Ultrassage, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980769 | Windmere Model DS-2 Foot BathILJ · Traditional | 03/27/1998SE |
| K932904 | Windmere Wand MassagerISA · Traditional | 02/17/1994SE |
| K933974 | Windmere Massage MateIRO · Traditional | 02/02/1994SE |
| K924237 | Windmere Prelude IIIISA · Traditional | 10/18/1993SE |
| K931086 | Windmere Vibra Touch Personal Body MassagerIRO · Traditional | 09/30/1993SE |
| K896245 | Plak Trac Powered ToothbrushJEQ · Traditional | 03/28/1990SE |
Questions and answers
When was Sound Relief cleared by the FDA?
Sound Relief (K912659) received a 510(k) decision of Substantially Equivalent on September 6, 1991, 81 days after the submission was received.
What is the product code of K912659?
The FDA product code is IRO – Vibrator, Therapeutic, a Class I (low risk) device regulated under 21 CFR 890.5975.