Panels › Physical Medicine › Product code IMD · Class 1
Pack, Hot Or Cold, Disposable
Regulation 890.5710
0510(k)s in 12 months (82 all time)
0recalls in 12 months (26 all time)
12recalls that name a 510(k)
Top companies in IMD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2024 | Safeguard US Operating LLC Kits of Convenience containing 1 of the 2 Item Numbers:
1. Item Number: 59-300 HAWK Warming Grid,
2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set.
Convenience kits labeled as f Open, Classified |
IMD | None listed |
| Sep 19, 2024 | Safeguard US Operating LLC HAWK Advanced Hypothermia Management Set, Item Number: 59-320 Open, Classified |
IMD | None listed |
| Sep 19, 2024 | Safeguard US Operating LLC HAWK Warming Grid, Item Number: 59-300 Open, Classified |
IMD | None listed |
| Jan 19, 2022 | Philips North America Llc Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 Open, Classified |
IMD | K936084 |
| Jan 19, 2022 | Philips North America Llc Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T Open, Classified |
IMD | K936084 |
| Jan 19, 2022 | Philips North America Llc Infant Heel Warmers w/strap, Reference # 989805603201 1223 Open, Classified |
IMD | K936084 |
| Jan 18, 2022 | Philips North America Llc Infa-Therm Transport Mattress, Reference Number 989805616831 1015 Open, Classified |
IMD | K936084 |
| Jul 8, 2019 | CooperSurgical, Inc. TransWarmer Warming Infant Transport Mattress, Model no. 20421
Product Usage:
The TransWarmer Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two ho Terminated |
IMD | K934631 |
| Apr 26, 2019 | PF Consumer Healthcare 1 LLC ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU:
a) F00573301020A
b) F00573301026X
c) F00573301009B
Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for th Terminated |
IMD | None listed |
| Apr 26, 2019 | PF Consumer Healthcare 1 LLC ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular a Terminated |
IMD | None listed |
| Oct 2, 2018 | Pfizer Inc. Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS
a) UPC 0573301311
b) UPC 0573301311
Product Usage:
Provides heat therapy for temporary relief of minor muscular Terminated |
IMD | None listed |
| Oct 2, 2018 | Pfizer Inc. Thermacare HeatWraps Menstrual
a) UPC 0573302002
b) UPC 0573302044
Product Usage:
Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches. Terminated |
IMD | None listed |
| Oct 2, 2018 | Pfizer Inc. Thermacare Muscle Pain Therapy HeatWraps:
a) UPC 0573301314
b) UPC 0573301303
Product Usage:
Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with ove Terminated |
IMD | None listed |
| Apr 4, 2016 | Philips Electronics North America Corporation eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima
A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur Terminated |
IMD | None listed |
| Apr 4, 2016 | Philips Electronics North America Corporation evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim
A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur Terminated |
IMD | K936084 |
| Dec 24, 2015 | Philips Electronics North America Corporation Cardinal Health Tiny Toes; 11470-010T Infant heel warmer Terminated |
IMD | K936084 |
| Apr 7, 2015 | CooperSurgical, Inc. CooperSurgical TransWarmer Infant Transport Mattress with WarmGel
P/N 20421
Private label:
NovaPlus TransWarmer Infant Heat Therapy Mattress with
WarmGel. P/N V6390
Provides warmth during transport o Terminated |
IMD | K934631 |
| Mar 19, 2015 | CooperSurgical, Inc. NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391
NovaPlus Brand Liquid Heal Warmer. Item #V6393
Single Use and Disposable
To provide gentle heat to increase blood flow and enhance infant Terminated |
IMD | K912715 |
| Mar 19, 2015 | CooperSurgical, Inc. MediChoice WarmGel Infant Heel Warmer, Item # 1643069911
MediChoice Liquid Infant Heel Warmer, Item # 1643069912
Single Use and Disposable.
Distributed by: Owens & Minor.
To provide gentle heat t Terminated |
IMD | K912715 |
| Mar 19, 2015 | CooperSurgical, Inc. Fisher Brand Gel Infant Heel Gel Warmers,
Cat. No.: 22-024647
Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646
To provide gentle heat to increase blood flow and enhance infant blood sample Terminated |
IMD | K912715 |
| Mar 19, 2015 | CooperSurgical, Inc. CooperSurgical Infant Heel Gel Warmers, P/N 20418
CooperSurgical The Infant Heal Warmer, P/N 2440
To provide gentle heat to increase blood flow and enhance
infant blood sample collection Terminated |
IMD | K912715 |
| Dec 16, 2010 | Pfizer Global ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609 Terminated |
IMD | None listed |
| Sep 26, 2008 | Becton Dickinson & Company Ace Heat Therapy, A BD Product
Up to 10 hours of Soothing Heat; Heat therapy for muscle and joint pain.
Apply Directly to Skin, Instant, Air-Activated Heat Patches
Distributed by: BD Medical, Franklin Terminated |
IMD | None listed |
| Mar 8, 2008 | Chattem Inc Aspercreme, Pain Relieving Creme with Aloe, Maximum Strength Formula, Net Wt 3oz (85g) with Bonus Icy Hot Heat Therapy Air Activated Heat Patch, 1 individually wrapped patch, 3.9" x 5.3" (10cm x 13.5c Terminated |
IMD | None listed |
| Mar 8, 2008 | Chattem Inc Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167-08335-2, Product Code 08335, 3.9" x 5.3" (10cm x 13.5 cm) each, 1 and 4 count patches, Distributed Terminated |
IMD | None listed |
| Mar 8, 2008 | Chattem Inc Icy Hot Heat Therapy , Air Activated Heat Patch, Back and Large Areas, UPC Code 0-41167-08330-7, Product Code 08330, 4.1" x 8.4" (10.5 cm x 2.1 cm) each, 1 and 3 count patches, Distributed by Chattem Terminated |
IMD | None listed |
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