510(k) K071710
- Device
- BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
- Applicant
- JOHNSON & JOHNSON CONSUMER PRODUCTS, INC.
- 510(k) number
- K071710
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-08-14
- Date received
- 2007-06-22
- Regulation
- 890.5710
- Classification name
- Pack, Hot Or Cold, Disposable
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAGMAR OETTE
- Address
- 201 Tabor Rd. Morris Plains NJ US 07950 07950
FDA Registration Numbers#
- 3008048783
- 3042277868
- 3008386507
- 3034669683
- 1836161
- 3010045207
- 3008264111
- 3008485841
- 3004824601
- 3016757941
- 3015363935
- 3018269545
- 3010182295
- 3002965034
- 3016778706
- 3008216220
- 3021595883
- 9616086
- 3043654665
- 3013473968
- 9615433
- 3004617746
- 3007299770
- 3007187674
- 3031232535
- 3004857344
- 1032347
- 1625392
- 3015220641
- 1054241
- 3004102812
- 3010531562
- 3006984851
- 3010097863
- 3012552736
- 3017166480
- 3029996046
- 3015272250
- 3033011342
- 3024689458
- 3011526963
- 3014065673
- 3003887292
- 3013684380
- 3008494300
- 3031184338
- 3010039589
- 3012466243
- 3027605322
- 3015397169
- 3005271071
- 3012421607
- 3015378469
- 1250045
- 3013632692
- 1835458
- 3038613041
- 8043323
- 3007838093
- 3009303243
- 3008676146
- 3017859599
- 1319302
- 3031595576
- 3030671612
- 3038103734
- 3009563903
- 3016170587
- 3010409218
- 3015414875
- 3008520652
- 3010580813
- 3016861904
- 3044563261
- 3005906953
- 3015173212
- 1055236
- 3016450032
- 3017591220
- 3004668337
Source Documents#
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 |
| 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 |
| K955788 | IMNI HOT PACKS | Omni Therm, Inc. | 1996-09-04 |
Legacy Summary#
summary
FDA Review#
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