510(k) K946382
- Device
- Skalpi 3200
- Applicant
- WISCCO DEVELOPMENT, INC.
- 510(k) number
- K946382
- Product code
- IRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-30
- Date received
- 1994-12-14
- Regulation
- 890.5975
- Classification name
- Vibrator, Therapeutic
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GUSTAVO RABIN
- Address
- 12419 Huston St. North Hollywood CA US 91607 91607
FDA Registration Numbers#
- 3024843804
- 3010605307
- 3007740394
- 3010975837
- 8044062
- 3009557417
- 3014158749
- 3043126945
- 3003454229
- 3017555752
- 3035785623
- 3012191805
- 3002849858
- 3015338588
- 3014344342
- 3015536186
- 3042284335
- 3035374386
- 2032856
- 3017415521
- 3042228064
- 3017264244
- 9616086
- 8040537
- 9613347
- 3017207289
- 3043618047
- 3009341046
- 3003746954
- 3033407717
- 3018360321
- 1061158
- 3016071154
- 3001744192
- 3009746042
- 3013201082
- 3016162044
- 3030648305
- 3013903013
- 3031238386
- 3030338883
- 9615108
- 9611425
- 3014561131
- 3012386142
- 3005033444
- 8040494
- 3002244637
- 3003123807
- 3020977186
- 3019604555
- 3005587124
- 3015977541
- 3016112555
- 3008469990
- 3006155598
- 2939821
- 3043513600
- 3010164891
- 3011258423
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IRO#
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|---|---|---|---|
| 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 |
| 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 |