510(k) K771002
- Device
- ICE BAND
- Applicant
- Norcliff Thayer, Inc.
- 510(k) number
- K771002
- Product code
- IME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-30
- Date received
- 1977-06-02
- 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
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3006852457
- 3015459201
- 3038130987
- 8043323
- 3008466086
- 3019505063
- 3011820722
- 3004777506
- 9680689
- 3018269548
- 2028253
- 1511629
- 3035374295
- 3033450607
- 3014947080
- 3030979014
- 3016446653
- 3016904840
- 3006755899
- 3011529314
- 3006008854
- 3023876581
- 3018135521
- 3008902816
- 2438205
- 3008956940
- 3004727093
- 3017621989
- 3016711531
- 3016585381
- 3004126239
- 9613918
- 3009168983
- 3018994219
- 3015337116
- 3030746897
- 1000328618
- 1519375
- 3006707030
- 3004956832
- 3016450032
- 3009960170
- 3013285519
- 3033011342
- 3031757047
- 3007942528
- 3043236409
- 3043749706
- 3009155880
- 1060934
- 3027500264
- 3010287652
- 3014982528
- 3038103734
- 3007076137
- 3028172072
- 3008264242
- 3002821232
- 3030956456
- 3037609256
- 3013533775
- 3017435733
- 3025194213
- 3008381107
- 3027321925
- 3013180212
- 9617420
- 3015344405
- 3011835632
- 3023339157
- 3004857344
- 1043214
- 3014344059
- 8010720
- 3009538555
- 3006984486
- 3019864920
- 3043654665
- 3006610790
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 |
| K830981 | MICROPAK MOIST HEAT PAD | Micropak Manufacturers, Inc. | 1983-06-03 |
| K830416 | ICY COLD ICE CAP | Ladora Ent. | 1983-03-10 |
| K823649 | THERMOELASTOMER HOT/COLD COMPRESS BK7186 | Fred Sammons, Inc. | 1983-01-21 |
| K823650 | THERMOELASTOMER HOT/COLD COMPRESS-7187- | 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 |