Head Facilitation Vibrator BK-5210
FDA 510(k) K771279 · Fred Sammons, Inc.
510(k) numberK771279
Submission
- Device name
- Head Facilitation Vibrator BK-5210
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- June 13, 1977
- Decision date
- August 26, 1977
- 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 |
More from Ultrassage, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880644 | Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional | 05/06/1988SE |
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | 04/01/1988SE |
| K831549 | Arm SlingsILI · Traditional | 06/30/1983SE |
| K831548 | SplintsILH · Traditional | 06/27/1983SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | 06/24/1983SE |
| K831543 | Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional | 06/24/1983SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
| K831552 | Sorbothane Visco Inner Sole PadKNP · Traditional | 06/08/1983SE |
Questions and answers
When was Head Facilitation Vibrator BK-5210 cleared by the FDA?
Head Facilitation Vibrator BK-5210 (K771279) received a 510(k) decision of Substantially Equivalent on August 26, 1977, 74 days after the submission was received.
What is the product code of K771279?
The FDA product code is IRO – Vibrator, Therapeutic, a Class I (low risk) device regulated under 21 CFR 890.5975.