FDA Product Code
FDA Product Code IRO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5975
510(k) Clearances — 65 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K955160 | COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER | Everapex Design & Marketing Corp. | 1996-02-08 | Traditional | PDF ↗ |
| K955250 | QI GONG MASSAGER | East Health Development Group, Inc. | 1996-02-08 | Traditional | PDF ↗ |
| K954203 | MASSAGER THERAPUTIC, ELECTRIC | Cisco Sales Corp. | 1995-12-11 | Traditional | PDF ↗ |
| K952916 | SHIATSU MASTER MASSAGER CUSHION | Kinsei Shiatsu, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K951414 | CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR | Champion Mfg. Corp. | 1995-08-11 | Traditional | PDF ↗ |
| K950441 | CONAIR FAMILY FITNESS BODY ENERGY | Conair Corp. | 1995-07-18 | Traditional | PDF ↗ |
| K946382 | SKALPI 3200 | Wiscco Development, Inc. | 1995-05-30 | Traditional | PDF ↗ |
| K950410 | CONAIR BODY AND SOLE | Conair Corp. | 1995-05-23 | Traditional | PDF ↗ |
| K944909 | WAHL FRESH FACE | Wahl Clipper Corp. | 1995-05-08 | Traditional | PDF ↗ |
| K950400 | HAND MASSAGE UNIT | Ultrassage, Inc. | 1995-03-30 | Traditional | PDF ↗ |
| K945603 | CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) | Headwaters, Inc. | 1995-02-09 | Traditional | PDF ↗ |
| K940582 | MASSAGING HELMET C.F. HANSEN DESIGN | Philco Ushuaia | 1995-01-30 | Traditional | PDF ↗ |
| K943730 | SQUEEZE PLAY | Conair Corp. | 1994-11-28 | Traditional | PDF ↗ |
| K940837 | WAHL(R) FOOT COMFORT MASSAGER | Wahl Clipper Corp. | 1994-06-09 | Traditional | PDF ↗ |
| K941412 | WAHL COMPACT COMFORT MASSAGER | Wahl Clipper Corp. | 1994-06-09 | Traditional | PDF ↗ |
| K934886 | NEXT WAVE PHYSIOACOUSTIC MATTRESS | Next Wave, Inc. | 1994-06-09 | Traditional | PDF ↗ |
| K931637 | A013 FEMI-FORM FACIAL MASSAGER | Fairform Mfg., Co., Ltd. | 1994-03-28 | Traditional | PDF ↗ |
| K931640 | AO11 BODY MASSAGER | Fairform Mfg., Co., Ltd. | 1994-03-28 | Traditional | PDF ↗ |
| K931638 | FO96 HANDY MASSAGER | Fairform Mfg., Co., Ltd. | 1994-03-28 | Traditional | PDF ↗ |
| K931639 | F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR | Fairform Mfg., Co., Ltd. | 1994-03-28 | Traditional | PDF ↗ |
| K923238 | SONASSAGE | Conair Corp. | 1994-02-02 | Traditional | PDF ↗ |
| K933974 | WINDMERE MASSAGE MATE | Windmere Corp. | 1994-02-02 | Traditional | PDF ↗ |
| K931819 | CARAPACE SUTURE REMOVAL TRAYS | Carapace, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K924519 | BODYTHERM | Conair Corp. | 1993-10-12 | Traditional | PDF ↗ |
| K924583 | HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER | Conair Corp. | 1993-10-12 | Traditional | PDF ↗ |
| K924584 | HEALTH ESSENTIALS FANCY PERSONAL MASSAGER | Conair Corp. | 1993-10-12 | Traditional | PDF ↗ |
| K924431 | HEALTLH ESSENTIALS PERSONAL MASSAGER | Conair Corp. | 1993-10-12 | Traditional | PDF ↗ |
| K924582 | HEALTH ESSENTIALS BODY CARE MASSAGER | Conair Corp. | 1993-10-12 | Traditional | PDF ↗ |
| K924581 | HEALTH ESSENTIALS MAXI MASSAGER | Conair Corp. | 1993-10-12 | Traditional | PDF ↗ |
| K931086 | WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER | Windmere Corp. | 1993-09-30 | Traditional | PDF ↗ |
| K920487 | MINI VIBRATOR | Alimed, Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K913439 | SONIX...THERAPEUTIC SONIC MASSAGE | Mcshirley Products, Inc. | 1992-01-22 | Traditional | PDF ↗ |
| K913998 | PAM PLUS | Kinetic Concepts, Inc. | 1992-01-08 | Traditional | PDF ↗ |
| K915242 | TOUCH N TONE 1 MASSAGER | Conair Corp. | 1991-12-20 | Traditional | PDF ↗ |
| K914705 | FO41 BODY MASSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | Traditional | PDF ↗ |
| K914704 | FO69 FANCY MASSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | Traditional | PDF ↗ |
| K914830 | A101 LITESSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | Traditional | PDF ↗ |
| K914829 | FO92 SEATING MASSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | Traditional | PDF ↗ |
| K914703 | F383 RECHARGEABLE MINI MASSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | Traditional | PDF ↗ |
| K914707 | F055 B.O. FANTASTIC RELAXER | Fairform Mfg., Co., Ltd. | 1991-12-09 | Traditional | PDF ↗ |
| K914706 | FO51/F151 GOLF MASSAGER | Fairform Mfg., Co., Ltd. | 1991-12-09 | Traditional | PDF ↗ |
| K914344 | MULTI-REACH II WAND MASSAGER | Conair Corp. | 1991-10-24 | Traditional | PDF ↗ |
| K912659 | SOUND RELIEF | Windmere Corp. | 1991-09-06 | Traditional | PDF ↗ |
| K912479 | MOTOR MASSAGE PILLOW | Supreme Import , Ltd. | 1991-08-09 | Traditional | PDF ↗ |
| K905836 | ULTRA WAVE 101 | Ako USA, Inc. | 1991-01-14 | Traditional | PDF ↗ |
| K903098 | MINI-VIBRATOR | Frank J. Biehl | 1990-07-25 | Traditional | PDF ↗ |
| K901931 | LEG EEZE | Jereva, Inc. | 1990-06-14 | Traditional | PDF ↗ |
| K896947 | CHIROPRACTIC MASSAGE PILLOW | Intl. Pacific Industrial Corp. (Usa), Inc. | 1990-01-02 | Traditional | PDF ↗ |
| K883913 | LA MASSEUSE | Sobel Shipping Co., Inc. | 1988-11-16 | Traditional | PDF ↗ |
| K871107 | VASOTRAIN 447 | Henley Intl. | 1987-05-29 | Traditional | PDF ↗ |
| K870972 | SONAFON, THERAPEUTIC MASSAGER | Electro Medica Office | 1987-04-13 | Traditional | PDF ↗ |
| K860159 | THUMPER (VIBRATOR/MASSAGER) | Wellness Innovations Corp. | 1986-02-06 | Traditional | PDF ↗ |
| K850495 | AKUFON THERAPEUTIC MASSAGER | Jansson A/S | 1986-01-03 | Traditional | PDF ↗ |
| K842379 | ELECTRO-SAGE MODEL 203 | Weingart, Inc. | 1984-08-10 | Traditional | PDF ↗ |
| K833370 | LINEAR VIBRATION A MCSHIRLEY PRODUCT | Mcshirley Products, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K830715 | NORELCO VIBRATING BOARD V900 | North American Philips Corp. | 1983-05-25 | Traditional | PDF ↗ |
| K821133 | ELECTRICAL VIBRATING DEVICE | Durham Electric Co. | 1982-07-09 | Traditional | PDF ↗ |
| K821633 | VARIABLE SPEED VIBRATOR, 120V 83-117 VIB | Fred Sammons, Inc. | 1982-06-11 | Traditional | PDF ↗ |
| K812902 | ACUPRESS VIBRATOR | Eicona Corp. | 1981-11-10 | Traditional | PDF ↗ |
| K810446 | VIBRATOR | Fred Sammons, Inc. | 1981-03-04 | Traditional | PDF ↗ |
| K810244 | PORTA-PULS MUSCLE STIMULATOR | General Physiotherapy, Inc. | 1981-02-26 | Traditional | PDF ↗ |
| K800250 | HMB-200 | Associated Mills, Inc. | 1980-03-25 | Traditional | PDF ↗ |
| K800018 | BK-5203 FACILITATION VIBRATOR ELECTRIC | Fred Sammons, Inc. | 1980-01-21 | Traditional | PDF ↗ |
| K771279 | HEAD FACILITATION VIBRATOR BK-5210 | Fred Sammons, Inc. | 1977-08-26 | Traditional | PDF ↗ |
| K761121 | ELECTRIC VIBRATOR | Fred Sammons, Inc. | 1976-12-02 | Traditional | PDF ↗ |
Product code IRO · Class I · Physical Medicine. Data: openFDA.