IRO · Vibrator, Therapeutic
Physical Medicine · 21 CFR 890.5975 · Class 1
Overview
| Product Code | IRO |
|---|---|
| Device Name | Vibrator, Therapeutic |
| Regulation | 21 CFR 890.5975 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A therapeutic vibrator is an electrically powered device intended for medical purposes that incorporates various kinds of pads and that is held in the hand or attached to the hand or to a table. It is intended for various uses, such as relaxing muscles and relieving minor aches and pains.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
Recent Cleared Devices (20 of 65)
Showing 20 most recent of 65 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K955250 | QI GONG MASSAGER | East Health Development Group, Inc. | Feb 8, 1996 | SN |
| K955160 | COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER | Everapex Design & Marketing Corp. | Feb 8, 1996 | SN |
| K954203 | MASSAGER THERAPUTIC, ELECTRIC | Cisco Sales Corp. | Dec 11, 1995 | SN |
| K952916 | SHIATSU MASTER MASSAGER CUSHION | Kinsei Shiatsu, Inc. | Aug 28, 1995 | SN |
| K951414 | CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR | Champion Mfg. Corp. | Aug 11, 1995 | SN |
| K950441 | CONAIR FAMILY FITNESS BODY ENERGY | Conair Corp. | Jul 18, 1995 | SESE |
| K946382 | SKALPI 3200 | Wiscco Development, Inc. | May 30, 1995 | SESE |
| K950410 | CONAIR BODY AND SOLE | Conair Corp. | May 23, 1995 | SESE |
| K944909 | WAHL FRESH FACE | Wahl Clipper Corp. | May 8, 1995 | SESE |
| K950400 | HAND MASSAGE UNIT | Ultrassage, Inc. | Mar 30, 1995 | SESE |
| K945603 | CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) | Headwaters, Inc. | Feb 9, 1995 | SN |
| K940582 | MASSAGING HELMET C.F. HANSEN DESIGN | Philco Ushuaia | Jan 30, 1995 | SN |
| K943730 | SQUEEZE PLAY | Conair Corp. | Nov 28, 1994 | SN |
| K941412 | WAHL COMPACT COMFORT MASSAGER | Wahl Clipper Corp. | Jun 9, 1994 | SN |
| K940837 | WAHL(R) FOOT COMFORT MASSAGER | Wahl Clipper Corp. | Jun 9, 1994 | SN |
| K934886 | NEXT WAVE PHYSIOACOUSTIC MATTRESS | Next Wave, Inc. | Jun 9, 1994 | SN |
| K931640 | AO11 BODY MASSAGER | Fairform Mfg., Co., Ltd. | Mar 28, 1994 | SESE |
| K931639 | F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR | Fairform Mfg., Co., Ltd. | Mar 28, 1994 | SESE |
| K931638 | FO96 HANDY MASSAGER | Fairform Mfg., Co., Ltd. | Mar 28, 1994 | SESE |
| K931637 | A013 FEMI-FORM FACIAL MASSAGER | Fairform Mfg., Co., Ltd. | Mar 28, 1994 | SESE |
Top Applicants
- Conair Corp. — 12 clearances
- Fairform Mfg., Co., Ltd. — 11 clearances
- Fred Sammons, Inc. — 5 clearances
- Wahl Clipper Corp. — 3 clearances
- Windmere Corp. — 3 clearances
