Product code IRO
- Device name
- Vibrator, Therapeutic
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5975
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K955250 | QI GONG MASSAGER | East Health Development Group, Inc. | 1996-02-08 |
| K955160 | COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER | Everapex Design & Marketing Corp. | 1996-02-08 |
| K954203 | MASSAGER THERAPUTIC, ELECTRIC | Cisco Sales Corp. | 1995-12-11 |
| K952916 | SHIATSU MASTER MASSAGER CUSHION | Kinsei Shiatsu, Inc. | 1995-08-28 |
| K951414 | CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR | Champion Mfg. Corp. | 1995-08-11 |
| K950441 | CONAIR FAMILY FITNESS BODY ENERGY | Conair Corp. | 1995-07-18 |
| K946382 | SKALPI 3200 | Wiscco Development, Inc. | 1995-05-30 |
| K950410 | CONAIR BODY AND SOLE | Conair Corp. | 1995-05-23 |
| K944909 | WAHL FRESH FACE | Wahl Clipper Corp. | 1995-05-08 |
| K950400 | HAND MASSAGE UNIT | Ultrassage, Inc. | 1995-03-30 |
| K945603 | CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) | Headwaters, Inc. | 1995-02-09 |
| K940582 | MASSAGING HELMET C.F. HANSEN DESIGN | Philco Ushuaia | 1995-01-30 |
| K943730 | SQUEEZE PLAY | Conair Corp. | 1994-11-28 |
| K941412 | WAHL COMPACT COMFORT MASSAGER | Wahl Clipper Corp. | 1994-06-09 |
| K940837 | WAHL(R) FOOT COMFORT MASSAGER | Wahl Clipper Corp. | 1994-06-09 |
| K934886 | NEXT WAVE PHYSIOACOUSTIC MATTRESS | Next Wave, Inc. | 1994-06-09 |
| K931638 | FO96 HANDY MASSAGER | Fairform Mfg., Co., Ltd. | 1994-03-28 |
| K931639 | F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR | Fairform Mfg., Co., Ltd. | 1994-03-28 |
| K931640 | AO11 BODY MASSAGER | Fairform Mfg., Co., Ltd. | 1994-03-28 |
| K931637 | A013 FEMI-FORM FACIAL MASSAGER | Fairform Mfg., Co., Ltd. | 1994-03-28 |
| K923238 | SONASSAGE | Conair Corp. | 1994-02-02 |
| K933974 | WINDMERE MASSAGE MATE | Windmere Corp. | 1994-02-02 |
| K931819 | CARAPACE SUTURE REMOVAL TRAYS | Carapace, Inc. | 1994-01-26 |
| K924519 | BODYTHERM | Conair Corp. | 1993-10-12 |
| K924581 | HEALTH ESSENTIALS MAXI MASSAGER | Conair Corp. | 1993-10-12 |
| K924582 | HEALTH ESSENTIALS BODY CARE MASSAGER | Conair Corp. | 1993-10-12 |
| K924583 | HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER | Conair Corp. | 1993-10-12 |
| K924584 | HEALTH ESSENTIALS FANCY PERSONAL MASSAGER | Conair Corp. | 1993-10-12 |
| K924431 | HEALTLH ESSENTIALS PERSONAL MASSAGER | Conair Corp. | 1993-10-12 |
| K931086 | WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER | Windmere Corp. | 1993-09-30 |
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| 00810140061423 | RENPHO | Joicom Corporation | 2024-11-19 |
| 00810140061430 | RENPHO | Joicom Corporation | 2024-11-19 |
| 00810140061515 | RENPHO | Joicom Corporation | 2024-11-19 |
| 10810140061420 | RENPHO | Joicom Corporation | 2024-11-19 |
| 10810140061437 | RENPHO | Joicom Corporation | 2024-11-19 |
| 10810140061512 | RENPHO | Joicom Corporation | 2024-11-19 |
| 00840295405568 | Therabody | Therabody, Inc. | 2024-11-08 |
| 00840295405575 | Therabody | Therabody, Inc. | 2024-11-08 |
| 00840295405582 | Therabody | Therabody, Inc. | 2024-11-08 |
| 07290103039677 | VSA 2 Hand-Leg support | MEDOC LTD. | 2023-06-20 |
| 07290103039660 | VSA 2 Handheld device | MEDOC LTD. | 2023-06-20 |
| 07290103039653 | VSA 2 Hand Held | MEDOC LTD. | 2023-06-20 |
| 00810036056687 | TheraFace | Therabody, Inc. | 2022-01-18 |
| 00810036056724 | TheraFace | Therabody, Inc. | 2022-01-18 |
| 00813859002886 | Pretika | PRETIKA CORPORATION | 2020-04-30 |
| 00813859002619 | Pretika | PRETIKA CORPORATION | 2019-07-01 |
| B108714GUNALXC0 | BTL Cellutone handpiece | BTL INDUSTRIES LIMITED | 2017-01-12 |
| B108714GUNALXCENUS0 | BTL Cellutone handpiece | BTL INDUSTRIES LIMITED | 2017-01-12 |
| B108744POCTENUS0 | BTL Cellutone | BTL INDUSTRIES LIMITED | 2017-01-12 |
| 07290103039004 | VSA-3000 Vibratory Sensory Analazer | MEDOC LTD. | 2016-09-24 |
| 07290103039509 | VSA-3000 Vibratory Sensory Analazer | MEDOC LTD. | 2016-09-24 |