510(k) K924023
- Device
- FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917
- Applicant
- FERNO
- 510(k) number
- K924023
- Product code
- IRQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-04-14
- Date received
- 1992-08-11
- Regulation
- 890.5950
- Classification name
- Unit, Heating, Powered
- 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
- ERIC N BESANKO
- Address
- 70 Weil Way Wilmington OH US 45177 45177
FDA Registration Numbers#
- 1032347
- 3015063984
- 3042228064
- 9611754
- 3012316249
- 3017264244
- 9710629
- 3017265430
- 3009308892
- 3009155756
- 3015397169
- 3043011436
- 3016677318
- 1836161
- 3011066654
- 3013689783
- 3011506263
- 3011407851
- 9616445
- 1057946
- 3013019295
- 3006622779
- 2087190
- 3008008970
- 3018448099
- 3035374295
- 3008466086
- 3012391195
- 3017555752
- 3008970204
- 3010362721
- 9610905
- 3015392301
- 3038319732
- 8030607
- 3017450375
- 3021656665
- 3029917416
- 3009273990
- 3013591868
- 8010177
- 9616086
- 9610612
- 3032109
- 3010227982
- 3003751839
- 3011533696
- 3014561131
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IRQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050524 | EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 | Marda Medical, Inc. | 2005-09-14 |
| K950350 | THEMALATOR. MODELS T-4-S, T-8-S, ETC. | Whitehall/Div Columbus Mckennon Corp. | 1995-03-24 |
| K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | Fred Sammons, Inc. | 1988-05-06 |
| K861340 | R1750 AND R1424 POWERED HEATING UNITS | Tri W-G, Inc. | 1986-05-02 |
| K832177 | PULSAIR MODEL SP-1 | Thermowave Medical Device Corp. | 1983-12-09 |
| K801625 | THERMOLATOR HEATING UNIT | Tru-Eze Mfg. Co., Inc. | 1980-07-28 |
Legacy Summary#
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FDA Review#
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