FDA Product Code
FDA Product Code IMD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5710
510(k) Clearances — 82 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221653 | InfaTherm Disposable Infant Warming Mattress | International Biomedical | 2022-10-06 | Traditional | PDF ↗ |
| K163295 | Infant Transport Mattress Warmer with Disc | Rapid Aid Corp. | 2017-07-24 | Traditional | PDF ↗ |
| K112547 | NEO NEST | Denovo Proucts, LLC | 2012-03-06 | Traditional | PDF ↗ |
| K082087 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2008-09-11 | Traditional | PDF ↗ |
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | Johnson & Johnson Consumer Products, Inc. | 2007-08-14 | Traditional | PDF ↗ |
| K021843 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2002-09-03 | Traditional | PDF ↗ |
| K982652 | ALLEGIANCE PORTA-WARM MATTRESS | Allegiance Healthcare Corp. | 1999-01-21 | Traditional | PDF ↗ |
| K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | Deroyal Industries, Inc. | 1998-02-26 | Traditional | PDF ↗ |
| K974190 | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER | Consolidated Products & Services, Inc. | 1997-11-19 | Traditional | PDF ↗ |
| K973770 | ALLEGIANCE KWIK HEAT WARM PERINEAL PACK | Allegiance Healthcare Corp. | 1997-11-13 | Traditional | PDF ↗ |
| K970399 | KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) | Allegiance Healthcare Corp. | 1997-04-03 | Traditional | PDF ↗ |
| K963689 | RECOVER ADULT VEIN WARMER | Florida Medical Industries, Inc. | 1996-12-12 | Traditional | PDF ↗ |
| K963768 | INSTANT HOT PACKS | Kick Ice, Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K963666 | INSTANT COLD PACK | Kick Ice, Inc. | 1996-10-30 | Traditional | PDF ↗ |
| K963220 | TEMPRA COLD PACK, REORDER NO. TC150 | Tempo Technology, Inc. | 1996-10-10 | Traditional | PDF ↗ |
| K955788 | IMNI HOT PACKS | Omni Therm, Inc. | 1996-09-04 | Traditional | PDF ↗ |
| K961176 | OMNI COLD GEL PACKS | Omni Therm, Inc. | 1996-09-04 | Traditional | PDF ↗ |
| K951033 | ANDELA DYNAMIC COOLING DEVICE | Candela Laser Corp. | 1996-08-15 | Traditional | PDF ↗ |
| K960624 | CERTI COOL INSTANT COLD COMPRESS | Certified Safety Mfg., Inc. | 1996-05-06 | Traditional | PDF ↗ |
| K954877 | OMNI COLD GEL PACKS | Omni Therm, Inc. | 1996-02-13 | Traditional | PDF ↗ |
| K953442 | RESTORE, THERMACELLS (HOT PACK I) | Neal Dunning Assoc., Inc. | 1995-10-31 | Traditional | PDF ↗ |
| K953542 | COLDGEL | Prism Technologies, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K953541 | INSTANT COLDGEL | Prism Technologies, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K950680 | INFANT HEEL WARMER | Baxter Healthcare Corp | 1995-08-23 | Traditional | PDF ↗ |
| K951383 | TEMPRA HEAT PACK | Tempra Technology, Inc. | 1995-06-01 | Traditional | PDF ↗ |
| K941245 | POLY-MEDICS HEAT PACK | Biomet, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K936084 | OMNI WARM GEL PACKS | Omni Therm, Inc. | 1994-03-31 | Traditional | PDF ↗ |
| K940336 | CERTI HEAT INSTANT HEAT COMPRESS | Certified Safety Mfg., Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K935569 | INSTANT HOT OR COLD DISPOSABLE PACK | Cryopak Industries, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K934631 | TRANSWARMER | Prism Technologies, Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K934673 | KACEY DISPOSABLE INFANT HEEL WARMER | K & C Medical, Inc. | 1994-02-02 | Traditional | PDF ↗ |
| K920760 | PERI-K PAD COLD PACK | Baxter Healthcare Corp | 1993-07-29 | Traditional | PDF ↗ |
| K926590 | ANAGO DISPOSABLE INSTANT COLD PACK | Anago, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K926589 | ANAGO WARM PACK | Anago, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K926137 | ANAGO FEM-COOL/FEM-COOL PETITE | Anago, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K920252 | CURAD KID SIZE INSTANT COLD PACK | Kendall Healthcare Products Co. Div.Of Tyco Health | 1992-02-11 | Traditional | PDF ↗ |
| K912715 | INSTANT WARM GEL PACK | Prism Technologies, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K904819 | SHUR-LOCK ICE WRAP SYSTEM | Conco Medical Co. | 1990-12-06 | Traditional | PDF ↗ |
| K902839 | LIBERTY HOT PACK AND LIBERTY KOLD PACK | Liberty Ent. | 1990-07-25 | Traditional | PDF ↗ |
| K901834 | INSTANT ICE PACK | Impact Packaging Corp. | 1990-05-03 | Traditional | PDF ↗ |
| K901778 | 3M HEAT COMFORT PORTABLE SELF-HEATING PAD | 3M Company | 1990-05-01 | Traditional | PDF ↗ |
| K895860 | MEDI-PACK | Heatmax Mfg., Inc. | 1990-01-02 | Traditional | PDF ↗ |
| K894926 | STAT-PAD | Hettel Accessories, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K890924 | THERMO-PACK | Medical Manufacturers, Inc. | 1989-03-14 | Traditional | PDF ↗ |
| K890553 | CP&S DISPOSABLE INSTANT COLD COMPRESS | Consolidated Products & Services, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K890554 | CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS | Consolidated Products & Services, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K883966 | HARE COLD PACK | Dyna Industries, Inc. | 1988-09-30 | Traditional | PDF ↗ |
| K880871 | GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER | John Wagner Associates, Inc. | 1988-05-20 | Traditional | PDF ↗ |
| K873364 | HYPERTHERM TECHNOLOGIES' HEAT COMPRESS | Hypertherm Technologies, Inc. | 1987-11-17 | Traditional | PDF ↗ |
| K871168 | INSTANT COLD COMPRESS, CHEMICAL TYPE | Lexington Industries | 1987-04-06 | Traditional | PDF ↗ |
| K871114 | INSTANT HEAT COMPRESS, CHEMICAL TYPE | Lexington Industries | 1987-03-25 | Traditional | PDF ↗ |
| K870832 | OXY-THERM | M.D. Intl., Inc. | 1987-03-12 | Traditional | PDF ↗ |
| K863507 | PHYSI. & NURSES BRAND INSTANT KOLD & HOT KOMPRESS | Physician & Nurses Mfg. Corp. | 1986-09-19 | Traditional | PDF ↗ |
| K860444 | MAZING HEAT DISPOSABLE WARM PACK | Leebryan Intl. | 1986-02-27 | Traditional | PDF ↗ |
| K853148 | HOT OR HEAT PACK | Matrix Intl. | 1985-09-25 | Traditional | PDF ↗ |
| K853045 | ALLY PORTABLE NOT PACK/PAD DISPOSABLE | Actin International, Inc. | 1985-09-06 | Traditional | PDF ↗ |
| K852610 | HOT PACK | Oriental Medical Supplies, Inc. | 1985-08-12 | Traditional | PDF ↗ |
| K850566 | MARUKYR-BAN / HOT OR HEAT PACK | Oriental Medical Supplies, Inc. | 1985-05-29 | Traditional | PDF ↗ |
| K850637 | EXOTHERMIC HEATING PAD | Travenol Laboratories, S.A. | 1985-04-25 | Traditional | PDF ↗ |
| K844224 | EIXO THERMUS HEATING PADS | Eixo Thermus | 1984-11-23 | Traditional | PDF ↗ |
| K820906 | SPENCO CRYOPRESS | Spenco Medical Corp. | 1982-05-13 | Traditional | PDF ↗ |
| K821046 | COMPRES PORTABLE HEAT PADS | S.C. Johnson & Son, Inc. | 1982-04-29 | Traditional | PDF ↗ |
| K820359 | HOT MINI 15 & HOT MINI 24 | Hot Mini International, Inc. | 1982-03-08 | Traditional | PDF ↗ |
| K820282 | ACE BRAND INSTANT COLD PACK | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-02-12 | Traditional | PDF ↗ |
| K813628 | BK-7182 INSTANT COLD PACK | Fred Sammons, Inc. | 1982-01-19 | Traditional | PDF ↗ |
| K811803 | JAPANESE HOTZIE | Consolidated Health & Sports Prod. | 1981-07-31 | Traditional | PDF ↗ |
| K811206 | SELF HEATING DISPOSABLE HEAT PAD | Ensar Corp. | 1981-05-21 | Traditional | PDF ↗ |
| K810633 | WONDER WARMER | Montvale Products, Inc. | 1981-03-26 | Traditional | PDF ↗ |
| K810693 | CURITY PERINEAL COLD PACK | The Kendal Co. | 1981-03-26 | Traditional | PDF ↗ |
| K810692 | CURITY PERINEAL WARM PACK | The Kendal Co. | 1981-03-26 | Traditional | PDF ↗ |
| K802252 | HOT CYCLE, A CHEMICAL TYPE HOT PACK | Signal West | 1980-10-03 | Traditional | PDF ↗ |
| K790993 | INSTANT HOT & COLD PACKS | Chase Mfg. Co. | 1979-09-07 | Traditional | PDF ↗ |
| K791675 | KWICK KOOLER | Stahlex Corp. | 1979-09-04 | Traditional | PDF ↗ |
| K790480 | TULANE HEAT-PACK | Tulane | 1979-04-03 | Traditional | PDF ↗ |
| K780426 | BODY WARMER | Q-Matic Corp. | 1978-04-27 | Traditional | PDF ↗ |
| K780603 | COLD PACK | Abco Dealers, Inc. | 1978-04-21 | Traditional | PDF ↗ |
| K780279 | ICE-PAK, PDI | Nice-Pak Products, Inc. | 1978-04-10 | Traditional | PDF ↗ |
| K780014 | COLD CYCLE, CHEMICAL COLD PACK | Signal West | 1978-02-21 | Traditional | PDF ↗ |
| K771660 | KWICK KOOLER | World Trade Assoc. | 1977-11-07 | Traditional | PDF ↗ |
| K770505 | SHAKE-N-WARM | Signal West | 1977-04-05 | Traditional | PDF ↗ |
| K760706 | MUL-T-PAD | Gaymar Industries, Inc. | 1976-10-06 | Traditional | PDF ↗ |
| K760441 | BODY WARMER (SHAKE-N-WARM) | Yamada Co., Ltd of Japan | 1976-09-16 | Traditional | PDF ↗ |
Product code IMD · Class I · Physical Medicine. Data: openFDA.