510(k) K953442
- Device
- RESTORE, THERMACELLS (HOT PACK I)
- Applicant
- NEAL DUNNING ASSOC., INC.
- 510(k) number
- K953442
- Product code
- IMD
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1995-10-31
- Date received
- 1995-07-17
- Regulation
- 890.5710
- Classification name
- Pack, Hot Or Cold, Disposable
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- NEAL DUNNING
- Address
- 8309 Bryant Dr. Bethesda MD US 20817 20817
FDA Registration Numbers
- 1450662
- 3015220641
- 3023341288
- 3030488262
- 3012314549
- 3013735158
- 9615433
- 3038103734
- 3006210673
- 3005621729
- 3015277818
- 3030671612
- 2110420
- 3015526491
- 1216677
- 3029952416
- 3010182295
- 3016170587
- 3007865243
- 3015392301
- 3008174904
- 1423537
- 3008676146
- 3017299525
- 3006943846
- 3008742818
- 3010675856
- 3012711490
- 3003887292
- 3042896810
- 2214133
- 8030358
- 9680689
- 3010370474
- 3031589938
- 3014632167
- 3044466317
- 3005083505
- 3017591220
- 3008386507
- 3005533873
- 3031233916
- 3031595576
- 3016050930
- 3008808082
- 3012480535
- 9680284
- 3016816791
- 3013034812
- 3023917
- 3004993527
- 3008384335
- 2415591
- 3008693666
- 1034116
- 3042276434
- 3008774899
- 3020978033
- 3016761372
- 3004605321
- 3012034017
- 3014683120
- 3038718579
- 3005739529
- 3005343641
- 9021987
- 3021590259
- 1032347
- 3016778706
- 3038624153
- 3015375647
- 3008216220
- 3011118556
- 3006455037
- 3015339737
- 2438774
- 3038637162
- 3038199417
- 3016426842
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Other 510(k) Records For Product Code IMD
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221653 | InfaTherm Disposable Infant Warming Mattress | International Biomedical | 2022-10-06 |
| K163295 | Infant Transport Mattress Warmer with Disc | Rapid Aid Corp. | 2017-07-24 |
| K112547 | NEO NEST | Denovo Proucts, LLC | 2012-03-06 |
| K082087 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2008-09-11 |
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | Johnson & Johnson Consumer Products, Inc. | 2007-08-14 |
| K021843 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2002-09-03 |
| K982652 | ALLEGIANCE PORTA-WARM MATTRESS | Allegiance Healthcare Corp. | 1999-01-21 |
| K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | Deroyal Industries, Inc. | 1998-02-26 |
| K974190 | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER | Consolidated Products & Services, Inc. | 1997-11-19 |
| K973770 | ALLEGIANCE KWIK HEAT WARM PERINEAL PACK | Allegiance Healthcare Corp. | 1997-11-13 |
| K970399 | KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) | Allegiance Healthcare Corp. | 1997-04-03 |
| K963689 | RECOVER ADULT VEIN WARMER | Florida Medical Industries, Inc. | 1996-12-12 |
| K963768 | INSTANT HOT PACKS | Kick Ice, Inc. | 1996-11-25 |
| K963666 | INSTANT COLD PACK | Kick Ice, Inc. | 1996-10-30 |
| K963220 | TEMPRA COLD PACK, REORDER NO. TC150 | Tempo Technology, Inc. | 1996-10-10 |
Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases