510(k) K830981
- Device
- Micropak Moist Heat Pad
- Applicant
- MICROPAK MANUFACTURERS, INC.
- 510(k) number
- K830981
- Product code
- IME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-03
- Date received
- 1983-03-29
- Regulation
- 890.5700
- Classification name
- Pack, Hot Or Cold, Reusable
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1929833
- 3038283966
- 1423537
- 3009125070
- 3014672091
- 3030630899
- 3027057394
- 3015525234
- 3031841433
- 3030956456
- 2438774
- 3012482148
- 2183164
- 3016711531
- 3016879560
- 3017417635
- 1052728
- 1222630
- 3030151584
- 3005555653
- 3009561590
- 3008687634
- 3025702939
- 2438205
- 3037007193
- 3010097171
- 3008364966
- 3017633586
- 3012709011
- 9710505
- 3021630959
- 3008959444
- 1218386
- 8043782
- 3012262584
- 3033858895
- 3030979014
- 9680284
- 3031595580
- 3017936723
- 9616086
- 3012782440
- 3004956832
- 1450743
- 3006400320
- 3033519
- 3006852457
- 2084346
- 3041276890
- 3004264602
- 3027321925
- 3030158784
- 3012386142
- 3011150256
- 2083373
- 3004777506
- 2938257
- 1038758
- 3009155756
- 3005630901
- 3015821396
- 3008970204
- 1422443
- 3013564290
- 3010359088
- 3005023997
- 3006948534
- 3015140199
- 1523547
- 3007222546
- 1832415
- 9710567
- 2030775
- 3013052700
- 3004727093
- 3004423487
- 3013787796
- 3030444262
- 3010805625
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IME#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923627 | COLD PACK | Friendmed Products | 1993-04-14 |
| K915876 | HOTPAD | Ten Comfort Corp. | 1993-02-12 |
| K921446 | HOT OR COLD PACK (THERMIPAQ) | Thermionics Corp. | 1992-07-13 |
| K905207 | MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS | Micro Surgical Instruments Corp. | 1991-01-22 |
| K882413 | SUBOCCIPITAL ICE PILLOW | Ferguson Medical | 1988-11-30 |
| K863654 | RE-HEATER, HOT PACK | K & L Ent. | 1986-10-23 |
| K832193 | NICE PACK | Universal Medical Instrument Corp. | 1983-08-31 |
| K831899 | ENSWELL | Dr. Micheal A. Sabia | 1983-07-07 |
| K830416 | ICY COLD ICE CAP | Ladora Ent. | 1983-03-10 |
| K823650 | THERMOELASTOMER HOT/COLD COMPRESS-7187- | Fred Sammons, Inc. | 1983-01-21 |
| K823649 | THERMOELASTOMER HOT/COLD COMPRESS BK7186 | Fred Sammons, Inc. | 1983-01-21 |
| K823814 | HOT/COLD PACK HOLDERS | Danek Medical, Inc. | 1983-01-14 |
| K822783 | FLEX ICE FREEZE PACK | Igloo Corp. | 1982-10-06 |
| K821636 | ATTACH-A-PAK | Fred Sammons, Inc. | 1982-06-11 |
| K820901 | COLD ROLL | North Bank Labs, Inc. | 1982-04-15 |